PHILIPPINES Law and Practice Contributed by: Mark Leo Bejemino, Maria Patricia Cruz and Edward King Chua, Villaraza & Angangco
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. 2.2 Regulatory Data and Market Exclusivity There are no specific laws or rules in the Philippines on data and market exclusivity in relation to orphan or paediatric medications, new indications, combina ‑ tions or reclassifications. 2.3 Acceptable Pre-Launch Preparations 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 test ‑ ing, using, making or selling the invention, including any data related thereto, solely for purposes reason ‑ ably related to the development and submission of information and the issuance of approvals by govern ‑ ment 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. 2.4 Publicly Available Drug and Patent Information 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, particu ‑ larly Administrative Order No 2024-0013, which sets out updated rules for the registration of pharmaceuti ‑ cal 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 applica ‑ tions and granted marketing authorisations is avail ‑ able through the FDA’s online database. The FDA
also maintains an updated list of APIs and their cor ‑ responding 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 rel ‑ evant patents. Consequently, patentees are not noti ‑ fied of FDA registrations that may potentially infringe existing patents, and must therefore independently monitor FDA registrations. Conversely, manufactur ‑ ers, sellers and distributors are advised to conduct freedom-to-operate searches to assess whether their products infringe, or may potentially infringe, existing patents. 2.5 Reimbursement and Pricing/Linkage Markets In the Philippines, the grant of a marketing authorisa ‑ tion 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 veri ‑ fying 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 market ‑ ing of a product regardless of the patent’s status. As a result, patentees are not notified of FDA registra ‑ tions 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.
3. Biosimilar Market Entry 3.1 Infringing Acts
The principles outlined in 2.1 Infringing Acts gener ‑ ally 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 pro ‑
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