PHILIPPINES Law and Practice Contributed by: Mark Leo Bejemino, Maria Patricia Cruz and Edward King Chua, Villaraza & Angangco
In life sciences and pharmaceutical cases, potential respondents may include suppliers, importers, manu ‑ facturers, local distributors/wholesalers, pharmacists, doctors and hospitals. In practice, however, respond ‑ ents usually consist only of suppliers, importers, man ‑ ufacturers 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 reg ‑ istration 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. 1.3 Preliminary Injunction Proceedings An application for the issuance of a preliminary injunc ‑ tion 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 estab ‑ lished: • 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 pre ‑ liminary 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 adjudi ‑ cating 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 pat ‑ ent rights-holder may apply for a temporary restrain ‑ ing 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 certifi ‑ cation from the patent-holder, the expert or the com ‑ petent 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 authori ‑ sations 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 sus ‑ pected 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.
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