PHILIPPINES Law and Practice Contributed by: Mark Leo Bejemino, Maria Patricia Cruz and Edward King Chua, Villaraza & Angangco
cesses. 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 prod ‑ uct has been introduced to the market by the patent- holder or an authorised party. 3.2 Data and Regulatory Exclusivity There are no specific laws or rules in the Philippines regarding data and market exclusivity for biologics and biosimilars. 3.3 Acceptable Pre-Launch Preparations 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 com ‑ mercialisation. 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 simi ‑ larity in terms of safety, efficacy and manufacturing processes. 3.4 Publicly Available Drug and Patent Information 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 proce ‑ dures for biologics and biosimilars compared to tra ‑ ditional chemical drugs or generics. For biologics, the FDA requires more detailed and specific documenta ‑
tion regarding the safety, efficacy and manufacturing processes, as biologics are derived from living organ ‑ isms. For biosimilars, the approval process involves demonstrating that the product is highly similar to the reference biologic in terms of clinical data, manufac ‑ turing process and quality control, but with no clini ‑ cally meaningful differences in safety and efficacy. 3.5 Reimbursement and Pricing/Linkage Markets The general principles outlined in 2.5 Reimbursement and Pricing/Linkage Markets regarding the lack of patent linkage in the Philippines apply equally to bio ‑ logics and biosimilars.
4. Patent Term Extensions for Pharmaceutical Products
4.1 Supplementary Protection Certificates 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 mecha ‑ nisms 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 jurisdic ‑ tion. Patent-holders must therefore rely solely on the original patent term for exclusivity. 4.2 Paediatric Extensions Paediatric extensions are not available in the Philip ‑ pines, and there are no mechanisms for extending the term of a patent, including extensions linked to pae ‑ diatric 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.
167 CHAMBERS.COM
Powered by FlippingBook