Life Sciences & Pharma IP Litigation 2026 Comparisons

Republic Act No 8293, also known as the Intellectual Property Code of the Philippines (IP Code), establishes the statutory framework for the protection of intellectual property rights in the Philippines. Under the IP Code, the right to a patent belongs to the inventor, their heirs or their assigns. When two or more persons have jointly made an invention, the right to a patent shall belong to them jointly. Consequently, any patentee – or anyone possessing a right, title or interest in a patented invention – whose rights have been infringed may institute an action against the infringer. This may include a licensee or any person with a legally traceable right or interest to the patented invention, provided that such action is not prohibited by the patentee. In such a case, the patentee is not required to be included as a party if he or she does not consent to participate in the action.

For a licensee, the licence must be recorded with the Intellectual Property Office of the Philippines (IPOPHL). If the licence arises from a technology transfer agreement, the agreement must further comply with the prohibited and mandatory clauses set forth in the IP Code; otherwise, the agreement is unenforceable.

Foreign nationals or entities not licensed to do business in the Philippines must:

• be a national of, domiciled in, or maintain a real and effective industrial establishment in a country that is a party to any convention, treaty or agreement on intellectual property rights or unfair competition to which the Philippines is also a party, or one that provides reciprocal rights to Philippine nationals; and
• not be engaged in business in the Philippines.

For nullity/revocation actions, the standing requirement is significantly relaxed. Under the IP Code, any interested person may institute the action.

Aside from regular courts, actions for patent infringement and patent cancellation may also be filed with the IPOPHL, whose decisions carry the same weight and legal effect as court decisions.

Under the IP Code, any unauthorised person who makes, uses, offers for sale, sells or imports a patented product, or who uses a patented process to manufacture, deal in, use, sell, offer for sale or import any product obtained directly or indirectly from such process, is liable for infringement. Likewise, anyone who actively induces patent infringement or provides the infringer with a component of a patented product – or a product produced by a patented process – while knowing that it is especially adapted for infringing the patent and is not suitable for substantial non-infringing use is liable as a contributory infringer, and is jointly and severally liable with the infringer.

In life sciences and pharmaceutical cases, potential respondents may include suppliers, importers, manufacturers, local distributors/wholesalers, pharmacists, doctors and hospitals. In practice, however, respondents usually consist only of suppliers, importers, manufacturers and local distributors/wholesalers.

The IPOPHL and Philippine healthcare regulatory authorities – particularly the Department of Health (DOH) and the Food and Drug Administration (FDA) – are not involved in infringement actions and are not required to be notified, except where a judgment includes the cancellation of a patent, licence or registration issued by such authorities. Nonetheless, actions for infringement or patent cancellation may be filed with the IPOPHL. Similarly, actions for the cancellation or revocation of licences or registrations issued by the DOH or FDA may be filed directly with those agencies.

An application for the issuance of a preliminary injunction may be filed at the time of filing the action for infringement or at any time during the pendency of the case. The earliest opportunity to apply for injunctive relief is at the time of instituting the case. To obtain a preliminary injunction, the following must be established:

• the applicant has a clear and unmistakable right to be protected;
• there is a material and substantial invasion of such right;
• there is an urgent need to prevent irreparable injury to the applicant; and
• there is no other ordinary, speedy and adequate remedy to prevent the infliction of irreparable injury.

For the purposes of granting a preliminary injunction, only prima facie evidence or a sampling is required – ie, the evidence must be sufficient to establish a given fact, or the group or chain of facts constituting the party’s claim or defence, and will remain sufficient if not rebutted or contradicted.

Prior to the resolution of the application for a preliminary injunction, a summons is issued requiring the respondent to file its comment. After the submission of the respondent’s comment and evidence, a hearing will be conducted to give the parties an opportunity to examine each other’s evidence. If the application for preliminary injunction is granted, the applicant is required to pay a cash bond determined by the adjudicating authority. If it is later shown that the applicant is not entitled to a preliminary injunction, the bond will be used to pay for the damages sustained as a result of issuing the injunction. In matters of urgency, the patent rights-holder may apply for a temporary restraining order (TRO), which is effective for only 20 days.

While the rules generally require notice and hearing, an ex parte TRO may be issued in cases of extreme urgency, which is effective only for 72 hours. A certification from the patent-holder, the expert or the competent authority stating that the products are infringing – and if it is determined that continued access to the products by the public poses a danger and risk to life, health and public safety – may be considered a matter of extreme urgency, with the potential to result in great injustice to the patent rights-holder.

In the Philippines, a mere threat of infringement is insufficient to serve as a basis for injunctive relief, as the law requires a material and substantial invasion of a right. At most, the rights-holder may send a cease-and-desist letter to the alleged infringer to inform it that its intended actions may constitute infringement. Such notice is also necessary because, under the IP Code, damages cannot be recovered for acts of infringement committed before the infringer knew, or had reasonable grounds to know, of the existence of the patent. In practice, rights-holders typically monitor potential infringement through publications issued by the FDA, which list recently approved market authorisations or product registrations.

In addition to seeking injunctive relief, a patent rights-holder may request the Bureau of Customs to monitor, inspect and issue alerts or hold orders against suspected infringing imports, thereby complementing the enforcement remedies available under the IP Code.

At present, the rules do not allow for the submission of protective letters. Likewise, there are no specific rules or jurisprudence setting out factors governing the grant of injunctive relief in life sciences-related cases.

An infringement action and a patent validity (nullity) proceeding are separate and distinct actions that may be filed and conducted independently. However, because a determination of validity directly affects the enforceability of a patent, a pending nullity proceeding may constitute a prejudicial question that must first be resolved before the infringement case can proceed. Accordingly, the court may suspend the infringement action pending the outcome of the validity challenge.

Nonetheless, in an infringement action, if the court finds the patent or any of its claims to be invalid, it may order the cancellation of the affected claims or of the entire patent. Such cancellation is thereafter recorded in the IPOPHL register and published in due course, producing the same effect as a formal nullity proceeding before the IPOPHL.

While third-party observations are allowed, there are no patent opposition proceedings in the Philippines. A patent nullity proceeding may only be initiated once the patent has been granted.

While there is no prescriptive period for instituting an infringement action, damages cannot be recovered for acts of infringement that occurred more than four years before the action is instituted. In contrast, patent invalidity (nullity) actions may be filed at any time during the term of the patent.

A party is notified of an infringement or nullity action through the service of summons or notice to answer, which may be effected personally, through substituted service, by registered mail or courier, or by electronic means when permitted by the IPOPHL or the courts. For parties located abroad, service may be made via registered mail, courier or electronic means, or through diplomatic or consular channels, which generally extends the service period. Summons or notices to answer are typically issued within a few days to a couple of weeks from the filing of the action.

All procedural deadlines – such as for filing answers, evidence and submissions – are counted from the date of valid service. Delays or difficulties in serving a foreign defendant correspondingly delay the commencement of these periods. Service must be completed before the case can proceed; no hearings or evidence deadlines run until service is perfected.

In an infringement action, once the complaint is filed, a summons is issued requiring the respondent to file a verified answer within 30 days. After the answer is filed, the case undergoes a pretrial conference and mediation to explore the possibility of amicable settlement. If no settlement is reached, the case proceeds to trial, where each party may present witnesses and evidence. For infringement actions filed with the IPOPHL, hearings typically commence within a few months of filing, and decisions are generally issued within two to three years, depending on case complexity and docket load. Court-filed infringement actions usually take longer, due to heavier caseloads. While hearings in court cases also begin within a few months, decisions are generally rendered after two to five years. These timelines may vary depending on pleadings, motions, discovery and the availability of parties and counsel.

In patent nullity proceedings, the respondent must submit a verified answer within 30 days from receipt of the notice. After submission, the parties are referred to mandatory mediation to explore settlement. If settlement fails, a preliminary conference is conducted for the submission, presentation, inspection and comparison of evidence. Thereafter, parties submit their respective position papers within an agreed period. Upon submission of the position papers, or upon the lapse of the period, the case is deemed submitted for decision.

Unlike in infringement actions, there are no hearings in patent nullity proceedings, and the decision is based merely on the pleadings submitted by the parties. Therefore, patent nullity cases are decided much faster, with decisions usually issued after one to two years.

An infringement action may only be filed after the patent serving as the basis for the action has been granted, and it covers damages only for acts of infringement committed within four years prior to the filing of the action.

In asserting different types of patents under the IP Code, product patents are generally easier to enforce because the infringing product can be examined directly, whereas process patents present greater evidentiary challenges, as the protected process may not be visible or readily accessible. Establishing infringement of process patents often requires technical expertise and more extensive discovery.

The IP Code provides for a reversal of the burden of proof in cases involving process patents, particularly when the patented process produces a new product or there is a substantial likelihood that the same product was made using the patented process, and the patentee cannot determine the exact process employed by the alleged infringer. In such cases, the burden shifts to the alleged infringer to demonstrate that the process used is different from the patented process. This rule addresses the inherent difficulty of proving infringement of processes that are not readily observable.

Pre-action discovery or disclosure is generally not available in the Philippines; discovery mechanisms under the rules may only be availed of after the commencement of an action.

Nonetheless, prior to filing an action, a person who desires to perpetuate his or her own testimony or that of another person regarding any matter may file a verified petition in the court of the place of the residence of any expected adverse party. The petition shall show:

• that the petitioner expects to be a party to an action in a court of the Philippines but is presently unable to bring it or cause it to be brought;
• the subject matter of the expected action and his or her interest therein;
• the facts which he or she desires to establish by the proposed testimony and his or her reasons for desiring to perpetuate it;
• the names or a description of the persons he or she expects will be adverse parties and their addresses so far as known; and
• the names and addresses of the persons to be examined and the substance of the testimony which he or she expects to elicit from each.

The petition shall ask for an order authorising the petitioner to take the depositions of the persons to be examined named in the petition for the purpose of perpetuating their testimony.

Whether the deposition is taken pre-action or during the pendency of an action, the deponent may only be examined regarding any matter, not privileged, that is relevant to the subject of the pending action, whether relating to the claim or defence of any other party, including the existence, description, nature, custody, condition and location of any books, documents or other tangible things, and the identity and location of persons having knowledge of relevant facts, subject to the following guidelines during presentation of the deposition as evidence during the hearing.

• Any deposition may be used by any party for the purpose of contradicting or impeaching the testimony of the deponent as a witness.
• The deposition of a party or of anyone who at the time of taking the deposition was an officer, director or managing agent of a public or private corporation, partnership or association that is a party may be used by an adverse party for any purpose.
• The deposition of a witness, whether or not a party, may be used by any party for any purpose if the court finds that:
1. the witness is dead;
2. the witness resides more than 100 km from the place of trial or hearing, or is out of the Philippines, unless it appears that his or her absence was procured by the party offering the deposition;
3. the witness is unable to attend or testify because of age, sickness, infirmity or imprisonment;
4. the party offering the deposition has been unable to procure the attendance of the witness by subpoena; or
5. upon application and notice, such exceptional circumstances exist as to make it desirable, in the interest of justice and with due regard to the importance of presenting the testimony of witnesses orally in open court, to allow the deposition to be used.
• If only part of a deposition is offered in evidence by a party, the adverse party may require him or her to introduce all of it that is relevant to the part introduced, and any party may introduce any other parts.

There are currently no rules providing for the admissibility of depositions taken in other jurisdictions. In general, the rule is that the deponent must be presented during the hearing to testify on his or her deposition, as a deposition is not a substitute for live testimony. Furthermore, materials such as affidavits or other evidence obtained from foreign jurisdictions must be apostilled or authenticated before they can be admitted in Philippine courts.

Search and seizure orders are available in both administrative and criminal proceedings to enforce intellectual property rights. An application for a search warrant may be filed even before the commencement of an action. However, if there is already a pending case, the application must be filed with the court where the case is pending.

A search warrant shall be issued only upon a showing of probable cause that a specific offence or violation has occurred. The application must describe with particularity the place to be searched and the items to be seized. The judge must personally examine the complainant and any witnesses under oath or affirmation, through either oral examination or written questions and answers based on facts personally known to them. The judge must review and attach the affidavits and sworn statements to the record. If the judge is satisfied that probable cause exists, the warrant may be issued.

The current rules do not provide for the applicability of search and seizure conducted in other jurisdictions.

Philippine courts have discretion to grant declaratory relief. Under the rules, any person with an interest under a deed, will, contract or other written instrument – or whose rights are affected by a statute, executive order or regulation, ordinance or any other governmental regulation – may bring an action before the court, before any breach or violation occurs, to determine any question of construction or validity and to obtain a declaration of his or her rights or duties. Nonetheless, the court’s action is discretionary, and it may refuse to act on the petition.

At present, existing rules and jurisprudence have not addressed the availability of declarations of non-infringement or “Arrow declarations”.

The Doctrine of Equivalents is recognised in the Philippines, allowing a patent-holder to assert infringement even when the allegedly infringing product or process does not literally fall within the patent claims but is equivalent to the claimed invention. In the Philippines, the Doctrine of Equivalents is assessed using three complementary tests.

• The insubstantial test – patent infringement occurs when the infringer appropriates the patented invention but makes only insubstantial changes. A change is considered insubstantial if a person skilled in the art would recognise it as merely a substitute for the replaced element.
• The triple identity test (also known as the function-means-and-results test) – infringement exists if the allegedly infringing device or process performs substantially the same function, achieves substantially the same result, and uses substantially the same means as the claimed invention.
• The all-elements test – each individual element of the patent claim is compared to the allegedly infringing product or process, rather than considering the invention as a whole.

The Doctrine of Ensnarement, the Formstein Defence and the concept of “disclosed but not claimed” have not yet been applied or adopted in the Philippines due to the relatively sparse patent jurisprudence. While they may be considered persuasive, they do not hold binding precedent under Philippine law.

There is no explicit legal obligation to “clear the way” ahead of a new product launch in the Philippines. However, businesses are generally advised to conduct thorough intellectual property due diligence to ensure that their products do not infringe on existing patents, trade marks or other IP rights. While the concept of “clearing the way” typically involves seeking a court declaration of non-infringement, such a procedure is not available in the Philippines, making this option unviable. Instead, companies can opt to conduct freedom-to-operate searches to identify potentially conflicting patents and develop strategies to avoid infringement risks.

Failure to clear the way or address potential IP conflicts can lead to legal consequences, such as infringement lawsuits, injunctions and financial liabilities, including damages and attorney’s fees. In addition, the IPOPHL may intervene in cases of infringement or bad faith filings. Therefore, while not a formal requirement, clearing the way through diligent IP searches is considered a prudent practice to mitigate the risk of disputes and the associated consequences.

Philippine courts may rely on expert evidence to determine issues of infringement and/or validity, particularly in cases requiring specialised knowledge, such as patent disputes.

In infringement actions where there is trial, a party’s expert witness is presented in court and is subject to cross-examination. On the other hand, in patent cancellation proceedings, expert evidence normally takes the form of an affidavit executed by an expert witness. Both parties are generally entitled to present their own respective expert witnesses, and multiple experts may be involved, depending on the complexity of the issues at hand. The opinion of an expert witness – who must possess special knowledge, skill, experience or training – is admissible as evidence in such cases. The expert is required to maintain impartiality, as they owe a duty to the court, and not to any party. While there are no strict limits on the length or amount of expert evidence, the court may set reasonable bounds for efficiency and fairness.

In terms of procedure, each party is free to instruct and present their expert witnesses, but these experts must adhere to the rules governing expert testimony. The court does not typically appoint expert witnesses, but it may do so in specific cases where the need for impartial expertise arises. Similarly, while a technical or scientific adviser may be appointed in complex cases, this is not a routine practice. In preliminary injunction (PI) proceedings, expert evidence may also be presented, but the use of experts in such cases is generally more limited compared to the main action, as PI proceedings are typically focused on urgent, procedural matters. Therefore, expert testimony in PI cases may be less comprehensive than in the main trial, depending on the circumstances.

Experiments may be used to prove/disprove infringement/validity. Such evidence must form part of the testimony of the person who conducted the experiment or who has personal knowledge of such experiment.

The forms of discovery available to the parties include depositions, written interrogatories, admission by adverse part, the production or inspection of documents or things, and physical and mental examination of persons. As long as relevant and necessary, the parties to a life sciences/pharma case may secure admissions or documents from the adverse party.

Under the IP Code, the following defences are available in infringement actions, which apply equally to cases involving life sciences:

• the patent – or any claim therein – that serves as basis for the infringement action is invalid;
• international exhaustion of patent rights for drugs and medicines;
• the infringing act is done privately and on a non-commercial scale or for a non-commercial purpose, provided that the use does not significantly prejudice the economic interests of the owner of the patent;
• the act consists of making or using the invention exclusively for experimental use, for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use;
• the Bolar exception in the case of drugs and medicines;
• the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared;
• the invention is used in any ship, vessel, aircraft or land vehicle of any other country entering the territory of the Philippines temporarily or accidentally;
• any prior user, who, in good faith was using the invention or has undertaken serious preparations to use the invention in their enterprise or business, before the filing date or priority date of the application on which a patent is granted; or
• any government agency or third person authorised by the government may exploit the invention even without agreement of the patent owner where doing so in the public interest, as determined by a judicial or administrative body, in case of national emergency, and public non-commercial use by the patentee, or when the demand for the patented drug or medicine is not adequately met by the patentee.

In the Philippines, an infringement action and validity proceeding may be initiated simultaneously. Nonetheless, the infringement action can be stayed on the ground that the validity proceeding serves as a prejudicial question.

Patents may be amended during the pendency of litigation (after the patent has been granted). However, post-grant patent amendments are limited to:

• narrowing the scope of protection;
• correcting obvious mistakes or clerical errors; and
• correcting errors made in good faith.

In no case may the amendment result in the patent disclosure exceeding what was contained in the original application.

Since patent litigation in the Philippines is relatively sparse, amendments during the pendency of a case are very rare.

Generally, cases are decided in the first instance by the trial judge or by the hearing officer of the IPOPHL, as the case may be. In infringement cases filed with the IPOPHL that involve highly technical issues, the Director of Legal Affairs may, in the exercise of discretion, constitute a Committee of Three composed of the Director of Legal Affairs as Chair and two members possessing experience or expertise in the field of technology to which the patent relates. Similarly, in an infringement action filed before the courts, the court may appoint two or more assessors who possess the scientific or technical knowledge necessary to assist in the resolution of the issues involved in the litigation.

In general, any unauthorised person who makes, uses, offers for sale, sells or imports a patented product, or who uses a patented process to manufacture, use, deal in, sell, offer for sale or import any product obtained directly or indirectly from such process is liable for patent infringement. In practice, infringement actions involving pharmaceutical products are typically triggered by the actual sale, distribution or importation of the patented product.

The securing of market authorisation or product registration with the Food and Drug Administration (FDA) – including approval of the brand name, packaging and labelling – is generally considered a preparatory act and does not, by itself, constitute infringement. At this stage, patentees usually issue cease-and-desist letters to place the applicant on notice of the potential legal consequences of such activities.

In the Philippines, applications for reimbursement, pricing or listing are not publicly available records, nor are requests to tender or offers to supply after patent term expiration.

Parallel importation is not considered as infringement if the drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorised to use the invention.

There are no specific laws or rules in the Philippines on data and market exclusivity in relation to orphan or paediatric medications, new indications, combinations or reclassifications.

In the Philippines, before a generic medicine can be commercialised, the manufacturer or importer must seek approval from the FDA. Since this requires the submission of data and test results, the acts of testing, using, making or selling the invention, including any data related thereto, solely for purposes reasonably related to the development and submission of information and the issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product are not considered infringement.

The Philippines does not rely on the Orange Book or any direct equivalent. Instead, it follows regulatory guidelines issued by the FDA and the DOH, particularly Administrative Order No 2024-0013, which sets out updated rules for the registration of pharmaceutical products and active pharmaceutical ingredients (APIs) intended for human use, aligning Philippine regulation with regional and global harmonisation efforts. It streamlines the registration process and classifies products into various categories, such as chemical drugs, biological drugs, biosimilars and generics, reflecting a more structured approach to market access.

Public information on marketing authorisation applications and granted marketing authorisations is available through the FDA’s online database. The FDA also maintains an updated list of APIs and their corresponding product classifications.

In 2006, the patent linkage system was eliminated in the Philippines, and intellectual property protection matters were removed from the FDA’s jurisdiction. As a result, the FDA may process product registration applications without verifying the existence of any relevant patents. Consequently, patentees are not notified of FDA registrations that may potentially infringe existing patents, and must therefore independently monitor FDA registrations. Conversely, manufacturers, sellers and distributors are advised to conduct freedom-to-operate searches to assess whether their products infringe, or may potentially infringe, existing patents.

In the Philippines, the grant of a marketing authorisation is not linked to patent status, nor are decisions on pricing and reimbursement. Following the elimination of the patent linkage system in 2006, the FDA may process product registration applications without verifying the existence of any relevant patents. Even if the FDA becomes aware of a valid patent, it is not required to take it into account, and may approve the marketing of a product regardless of the patent’s status.

As a result, patentees are not notified of FDA registrations that may potentially infringe existing patents and must therefore independently and periodically monitor FDA registrations. Conversely, manufacturers, sellers or distributors are advised to conduct freedom-to-operate searches to assess whether their products infringe, or may potentially infringe, existing patents.

The principles outlined in 2.1 Infringing Acts generally apply to biologics and biosimilars, with a few key differences. For biologics, the patent rights are often more complex due to the nature of the product, which involves more sophisticated manufacturing processes and may include patents related to the compound, formulation, methods of use or manufacturing processes. In the case of biosimilars, while they are intended to be highly similar to an approved reference biologic, patent infringement issues can arise if the biosimilar infringes on the reference biologic’s existing patents, such as those covering the composition or methods of production.

Parallel importation for biologics and biosimilars is treated similarly to other pharmaceutical products and is not considered infringement as long as the product has been introduced to the market by the patent-holder or an authorised party.

There are no specific laws or rules in the Philippines regarding data and market exclusivity for biologics and biosimilars.

The information relayed in 2.3 Acceptable Pre-Launch Preparations remains largely the same in the context of biologics and biosimilars, as both types of products require approval from the FDA before commercialisation. However, for biologics and biosimilars, the regulatory framework is more complex due to the distinct nature of biologics, which are derived from living organisms, and biosimilars, which are designed to be highly similar to an existing biologic product. While the acts of testing, making or selling biologics or biosimilars for the purposes of obtaining regulatory approval are not considered infringement (similar to generic drugs), the approval process for biosimilars includes additional requirements to demonstrate similarity in terms of safety, efficacy and manufacturing processes.

In the Philippines, the process for obtaining marketing authorisation for biologics and biosimilars follows the same general framework as outlined in Administrative Order 2024-0013, which streamlines the registration process for all pharmaceutical products, including biologics and biosimilars. However, there are some differences in the regulatory requirements and procedures for biologics and biosimilars compared to traditional chemical drugs or generics. For biologics, the FDA requires more detailed and specific documentation regarding the safety, efficacy and manufacturing processes, as biologics are derived from living organisms. For biosimilars, the approval process involves demonstrating that the product is highly similar to the reference biologic in terms of clinical data, manufacturing process and quality control, but with no clinically meaningful differences in safety and efficacy.

The general principles outlined in 2.5 Reimbursement and Pricing/Linkage Markets regarding the lack of patent linkage in the Philippines apply equally to biologics and biosimilars.

The Philippines does not have a system for granting Supplementary Protection Certificates (SPCs) or any similar form of patent term extension. All patents are subject to a uniform 20-year term, regardless of the type of invention, the identity of the applicant or the length of regulatory approval processes. There are no specific rules addressing SPCs or analogous mechanisms for products protected by multiple patents, nor for combination products.

Accordingly, there are no SPC-related manufacturing waivers, export waivers or comparable exceptions in the Philippines, as these concepts are inherently linked to SPC regimes that do not exist in the jurisdiction. Patent-holders must therefore rely solely on the original patent term for exclusivity.

Paediatric extensions are not available in the Philippines, and there are no mechanisms for extending the term of a patent, including extensions linked to paediatric studies or paediatric regulatory compliance. Accordingly, once a patent expires at the end of its 20-year term, it enters the public domain regardless of whether paediatric clinical studies were conducted or paediatric indications were approved.

There are no laws or rules that specifically govern paediatric-use marketing authorisations in the Philippines.

Orphan medicines extensions are not available in the Philippines.

Undertakings as to damages are required from patentees or exclusive licensees seeking a preliminary injunction. This undertaking is typically provided in the form of a bond, which serves as a financial guarantee to compensate the defendant if the injunction is later found to have been wrongly granted. The bond remains in force for the duration of the preliminary injunction, which usually lasts until the final resolution of the case. If the injunction is lifted or reversed, the bond may be forfeited to compensate the defendant for any damages caused. In life sciences patent cases, where the injunction could prevent the sale or distribution of medicines or medical devices, the bond might also account for economic damages like lost profits and reputational harm.

Third parties, such as national health services, are generally not entitled to the undertaking, as the bond primarily benefits the defendant who is subject to the injunction. The amount of the bond is discretionary and determined by the court, based on the circumstances of the case, but there are no fixed rules for calculating the quantum.

A preliminary injunction is a provisional remedy that cannot exist independently and must be anchored to a main action. If the main action is terminated, the injunction is automatically dissolved. Once issued, a preliminary injunction is initially effective for a period of 20 days from service. Within this period, a hearing is conducted to determine whether the injunction should be extended to remain in effect while the main case is pending.

A preliminary injunction becomes enforceable upon service of the written order on the defendant. Service is generally required to be personal, although alternative modes may be permitted, such as registered mail or publication. The injunction takes effect upon service, and the timing of service is critical in determining its enforceability.

A preliminary injunction may be dissolved upon the filing of a counterbond and upon showing that the continuation of the injunction would cause irreparable damage, while the applicant can be fully compensated for any damages suffered. The amount of the counterbond depends on the nature of the case and the relief sought, as no fixed amount is prescribed by law.

A party may request a stay of a preliminary injunction while an appeal is pending. As a general rule, injunctions that are immediately executory are enforceable upon issuance and are not stayed by an appeal unless the court orders otherwise. However, a stay may be granted if the requesting party shows that it will suffer irreparable harm without the stay and that there are substantial grounds to question the injunction on appeal. The appellate court may, at its discretion, suspend, modify or restore the injunction, subject to conditions such as the posting of a bond to protect the opposing party.

A final injunction becomes enforceable only after trial, following the court’s determination that the applicant is entitled to have the complaint permanently enjoined. The injunction forms part of the final decision and becomes effective only when the decision becomes final and executory, meaning the appeal period has passed without any appeal being filed. No bond is required to enforce a final injunction, as this is part of the court’s final adjudication. The effectivity of the final injunction is tied to the service of the order on the enjoined party, and the injunction is enforceable only once it has been properly served.

The enforcement of a final injunction is carried out by the court’s process server, who is responsible for personally serving the order to the enjoined party. If personal service is not possible, alternative methods such as registered mail or publication can be used. If the enjoined party fails to comply with the injunction, they may be held in contempt, which can result in penalties, including fines or imprisonment. The court has the authority to impose further measures to ensure the enforcement of the injunction. The enforcement procedure typically occurs swiftly, but timelines may be affected by the defendant’s co-operation and any legal challenges raised.

Finally, it is possible to obtain a stay of a final injunction pending appeal, although such relief is not automatic. Generally, judgments in actions for injunction are immediately executory and are enforceable upon rendition, and an appeal does not stay their execution unless otherwise ordered by the court. Nonetheless, on appeal, the appellate court has the discretion to suspend, modify, restore or grant the injunction or related relief.

To obtain a stay, the appealing party must demonstrate that it will suffer irreparable harm if the injunction is enforced during the pendency of the appeal and that there are substantial or serious grounds raising doubt regarding the correctness of the judgment. The court will also weigh the relative harm to both parties in deciding whether to grant a stay.

A stay of execution may be made subject to such terms as the court may deem proper, including the posting of a bond or other security to protect the rights of the adverse party. A bond may therefore be required in order to lift or suspend the effect of a final injunction pending appeal, with the amount determined by the court based on the potential damages or prejudice that the enjoined party may suffer if the appeal is unsuccessful; there is no fixed or typical quantum, as it varies according to the facts and circumstances of each case.

The Philippine courts have discretion to award damages in lieu of an injunction in certain cases. If the court determines that granting an injunction would be unjust or overly burdensome, or would cause disproportionate harm, it may opt to award damages as a remedy instead. This is particularly relevant when the harm to the applicant can be adequately compensated through monetary damages. In such cases, the court balances the nature of the harm to both parties against the need for an equitable resolution.

Proportionality and public interest arguments are highly relevant in life sciences and pharma patent litigation. Courts may take broader societal considerations into account when deciding whether to grant or limit injunctive relief, such as access to medicines, public health concerns or the impact on competition. In cases where the injunction could restrict access to essential drugs or harm public welfare, the court may opt for a more limited or proportional injunction, or may even deny an injunction entirely in favour of a different remedy, such as damages. The court’s focus will often be on finding a balance between protecting the patent and its societal impact.

Damages can be:

• actual or compensatory;
• moral;
• nominal;
• temperate or moderate;
• liquidated; or
• exemplary or corrective.

Actual damages pertain to pecuniary loss suffered by the complainant as he or she may duly prove. Moral damages may be recovered if they are the proximate result of the defendant’s wrongful act for omission, and cover:

• physical suffering;
• mental anguish;
• fright;
• serious anxiety;
• besmirched reputation;
• wounded feelings;
• moral shock;
• social humiliation; and
• similar injury.

Nominal damages are adjudicated in order that a right of the plaintiff that has been violated or invaded by the defendant may be vindicated or recognised, and not for the purpose of indemnifying the plaintiff for any loss suffered. Temperate damages, which are more than nominal but less than compensatory damages, may be recovered when the court finds that some pecuniary loss has been suffered but its amount cannot, from the nature of the case, be provided with certainty. Liquidated damages are those agreed upon by the parties to a contract, to be paid in case of breach thereof. Exemplary or corrective damages are imposed by way of example or correction for the public good, in addition to moral, temperate, liquidated or compensatory damages.

The primary considerations when determining and computing damages are lost profits, reasonable royalty or account of profits.

• Lost profits are calculated based on the amount the patentee would have earned if the infringement had not occurred, typically by comparing the sales made by the infringer to what the patentee would have earned.
• Reasonable royalty is based on a hypothetical negotiation between the parties and determines what the infringer would have paid if they had licensed the patent.
• Account of profits requires the infringer to pay the profits they earned from using the patented invention.

If the patentee/exclusive licensee has no competing product, lost profits might not be an option, and damages are more likely calculated via reasonable royalty or account of profits.

In the pharma, biopharma and medical device industries, damage awards are primarily calculated based on lost profits and royalty. These methods aim to compensate the patentee or exclusive licensee for the harm caused by the infringement, particularly in cases where the infringement has resulted in lost market share or sales. Special awards like treble damages for wilful infringement are not automatically available in the Philippines, but courts may award such damages in cases of wilful infringement, based on the severity of the infringement or the infringer’s conduct. While such treble damages are rare, the court has the discretion to increase the damages up to three times the actual or compensatory damages if the infringement was egregious or carried out in bad faith.

No damages can be recovered for acts of infringement committed more than four years before the institution of the action for infringement. Moreover, damages cannot be recovered for acts of infringement committed before the infringer knew of the patent, or had reasonable grounds to know of it. It is presumed that the infringer had known of the patent if the words “Philippine Patent” with the number of the patent are placed on the patented product, or on the container or package in which the article is supplied to the public, or on the advertising material relating to the patented product or process.

Interest on the damages accrues only when the judgment of the court awarding a sum of money becomes final and executory. The rate of legal interest shall be 6% per annum from such finality until its satisfaction, with this interim period being deemed to be by then an equivalent to a forbearance of credit.

In the context of criminal and civil cases, damages refer to monetary compensation awarded to an injured party for harm caused by a wrongful act. Civil damages are typically considered in a separate quantum hearing after the court has determined liability in the trial. These damages are aimed at compensating the injured party for actual loss, moral suffering or other damages arising from the defendant’s wrongful conduct. The prosecution of a criminal case in the Philippines typically includes the civil aspect for the recovery of damages by the offended party, unless the injured party chooses to waive their claim for damages or opts to file a separate civil action for damages. Criminal damages typically include penalties such as fines or imprisonment, whereas civil damages focus on compensating the injured party.

Moreover, an alleged infringer who was later declared not to be an infringer may claim damages from the complainant, provided this is one of the resolutions it sought in its answer.

Lastly, third parties are generally not allowed to claim damages in proceedings to which they are not a party. In such cases, they cannot simply join an ongoing case to claim damages. Instead, third parties must file a separate claim for damages in a new action, independent of the original proceedings.

The prevailing party may recover legal costs, subject to the court’s discretion to determine, reduce or otherwise modify the amount. Where the court finds that an action or appeal is frivolous, it may impose costs in double or treble the usual amount. Any allegation in a pleading made without reasonable cause and subsequently found to be untrue may render the offending party liable for the reasonable expenses necessarily incurred by the opposing party as a result thereof. Such expenses shall be fixed by the court and taxed as costs. Furthermore, where the record contains unnecessary, irrelevant or immaterial matters, the party at whose instance such matters were included or printed shall not be allowed to recover, as costs, any expenses incurred for its preparation, certification or printing.

Under Philippine rules, attorney’s fees shall not form part of the legal cost, being an independent undertaking between the party and his or her lawyer. Nonetheless, attorney’s fees may be claimed as part of actual damages subject to the submission of evidence of the pecuniary amount.

Subject to the discretion of the court, the negative conduct of the claimant/plaintiff may be taken into consideration in determining the amount of damages or costs to which he or she shall be entitled.

Trade mark disputes involving life sciences and the pharma sector are common in the Philippines, and usually involve the registrability of brand names of medicines under the IP Code. Aside from the distinctiveness requirement, brand names of medicines should not be identical or similar to any of the word stems listed as International Nonproprietary Names. Otherwise, the brand names will be deemed generic and not registrable.

While copyright disputes involving life sciences and the pharma sector are not common in the Philippines, product packaging and drug package inserts – which are protected as copyrightable works – may give rise to copyright infringement.

Trade secret disputes involving life sciences and the pharma sector are not common in the Philippines. However, since product formulations can be protected as a trade secret through contractual agreement, breach of said agreement may give rise to a trade secret dispute.

Generally, an appeal is a matter of right in the Philippines. However, a further appeal of a decision rendered on an appealed case becomes discretionary.

An order granting a preliminary injunction may be dissolved upon a motion showing that, although the applicant is entitled to the injunction, the issuance or continuance thereof would cause irreparable damage to the enjoined party, while the applicant can be fully compensated for any damages they may suffer, provided that they file a bond. The motion to dissolve shall be set for hearing within 48 hours from its filing, and shall be resolved after both parties have presented their respective evidence.

However, the denial of an application for a preliminary injunction is not appealable, nor is an order dissolving a previously issued injunction or denying a motion to dissolve. Nonetheless, the aggrieved party may challenge such order by filing a Petition for Certiorari with the Court of Appeals within 60 days from notice of the order, alleging that the issuance thereof was attended by grave abuse of discretion amounting to lack or excess of jurisdiction. It must be emphasised that a Petition for Certiorari constitutes a separate and independent action, and not a continuation or appeal of the case from which the order granting or denying the preliminary injunction arose. The decision of the Court of Appeals may then be appealed to the Supreme Court within 15 days from receipt thereof; this period is extendible by 30 days.

If a decision on the main action, whether on the infringement or validity, was issued by the Adjudication Officer, a party has 15 days (extendible by 15 days) from receipt to appeal the decision before the Director of Legal Affairs. The decision of the Director of Legal Affairs may then be appealed to the Office of the Director General (ODG) of the IPOPHL within 30 days (extendible by 15 days) from receipt of the decision. Subsequently, the Court of Appeals’ decision may be appealed to the Supreme Court within 15 days from receipt thereof, extendible by 30 days. The Supreme Court’s decision is final and is not subject to further appeal. Generally, appeals are not de novo; new evidence or arguments are typically not entertained. Up to the Court of Appeals, parties may still raise factual issues and challenge the factual findings of the lower court, in addition to legal arguments. However, in the Supreme Court, which is not a trier of facts, only questions of law may be raised.

If the decision granting injunction is overturned on appeal, the injunction will be revoked, lifted or dissolved upon the finality of the decision and upon motion to the court of origin. However, the mere fact that the patent subject of the controversy becomes invalid does not affect the validity of the injunction. In such cases, the injunction remains in force until the tribunal or court that issued it specifically rules on its continued effect.

Patent litigation appeals from administrative decisions of the IPOPHL are first decided by the Director General, who reviews the record and arguments without forming a panel of judges. Further appeals may be taken to the Court of Appeals and ultimately the Supreme Court, where decisions are rendered by regular appellate judges, not specialised patent judges, although technical experts may be consulted as needed.

In both civil and criminal patent litigation, appeals follow the same hierarchy: decisions of the Regional Trial Court may be appealed to the Court of Appeals and, on questions of law, to the Supreme Court. Appellate courts generally review the trial record and legal arguments, and the matter is typically not heard de novo, except for limited factual questions as allowed by law.

In 2020, the Supreme Court issued the Rules of Procedure for Intellectual Property Rights Cases. These rules apply only to proceedings before the trial courts designated as Special Commercial Courts when handling intellectual property rights cases. Cases before the IPOPHL continue to be governed by the IP Code and the relevant rules of procedure before the Bureau of Legal Affairs or the ODG of the IPOPHL.

Aside from court litigation and IPOPHL administrative proceedings, other relevant forums and procedures for life sciences and pharmaceutical IP enforcement include:

• border enforcement actions before the Bureau of Customs, where rights holders may record their IP rights and request the detention or seizure of suspected infringing or counterfeit pharmaceutical products; and
• regulatory actions before the Philippine Food and Drug Administration against unauthorised or unsafe products.

As the Philippines does not have a specialised forum equivalent to the US International Trade Commission, a customs enforcement is administrative in nature.

The EU’s Unified Patent Court (UPC) has no direct effect on Philippine patent litigation, as the Philippines is not part of the EU patent system; while UPC jurisprudence may be of persuasive interest in Philippine jurisdiction, it has no binding impact on IP enforcement or litigation.

Mediation and arbitration are the principal ADR mechanisms available for life sciences and pharmaceutical IP disputes. In proceedings before the IPOPHL, after submitting the respondent’s responsive pleading in a cancellation, infringement or other IP case, the matter is automatically referred to the Alternative Dispute Resolution Services of the Bureau of Legal Affairs, where the parties are required to undergo mandatory mediation to explore an amicable resolution of the case.

In proceedings before trial courts, after pre-trial, the parties will be referred to mandatory court-annexed mediation. If the judge of the court to which the case was originally raffled is convinced that settlement is still possible, the case may be referred to another court for judicial dispute resolution.

In general, market competition and potential antitrust activities are closely monitored by the Philippine Competition Commission, implementing Republic Act No 10667 or the Philippine Competition Act. However, there are no rules or guidelines that apply specifically to the pharmaceutical industry.

Group claims (class actions) are available in the Philippines, including disputes involving allegedly defective medicines or medical devices, although they remain relatively uncommon in the life sciences and pharmaceutical sector. Class actions are governed primarily under the Rules of Civil Procedure, which allow a representative suit when the subject matter of the controversy is one of common or general interest to such a high number of persons that it is impracticable to join all as parties.

In pharma-related cases, class actions may be anchored on laws such as the Consumer Act of the Philippines, which addresses unsafe or defective consumer products, and the Food and Drug Administration Act, which regulates the safety, efficacy and quality of drugs and medical devices.