Pharmaceutical patents (pharma patents) are primarily concerned with chemical compounds that are useful in the treatment of disease, the uses of those compounds in treating diseases, formulating the compounds as medications, and processes for making the compounds.

What are pharmaceutical incentives? In the EU, protection mechanisms and incentives for medicinal products, bundled under the term pharmaceutical incentives (PIs), exist. PIs consist of certain legislative measures which grant originator pharmaceutical companies (originators) a certain benefit compared to companies which sell medicinal products with the same active substance for a much lower price (generic or biosimilar companies)—ranging from market protection (MP) to a prolongation of patent rights to several years of market exclusivity for a medicinal product. Rationale behind PIs PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. Whereas innovation and discovery often require a substantial time and financial investment, a minimum effort is needed to use the knowledge obtained by such discovery afterwards. Indeed, when a generic or biosimilar company copies an invention, it often does not have to endure the very substantial research and development (R&D) costs of developing such invention and, hence, is able to

European pharmaceutical industry associations AESGP, EFPIA and Medicines for Europe has criticised the European Commission's upcoming study on costs for implementing quaternary-level treatment upgrades under the Urban Wastewater Treatment Directive (UWWTD). The associations claim the Commission has not consulted affected industries on the study, which they say merely updates figures for inflation rather than conducting a comprehensive sector assessment. The UWWTD, adopted in 2024, introduces an Extended Producer Responsibility scheme requiring pharmaceutical and cosmetics industries to pay for advanced wastewater treatment. Member States' analyses suggest Commission cost estimates were underestimated by 300-600%, potentially raising costs from €1.18bn to over €7bn annually. Poland has initiated legal proceedings against the directive at the Court of Justice of the European Union, while France and Germany have called for revision.

This Practice Note discusses pharmaceutical patents, and the effect of regulations associated with the approval of new medicinal products. Pharmaceutical patents (pharma patents) are a very specific part of the IP canon. They are primarily concerned with chemical compounds that are useful in the treatment of disease, the uses of those compounds in treating diseases, formulating the compounds as medications, and processes for making the compounds. For more information about patents for new chemical entities and small molecules, see Practice Note: Patents for new chemical entities and small molecules and for more information about biotechnology patents, see Practice Note: Biotechnology patents. Despite Brexit, the UK remains part of the European patent system because the European Patent Office (EPO) and the European Patent Convention (EPC) (the international treaty which establishes the procedure for the granting of European patents by the EPO) are both independent of the EU. The UK has simply become another non-EU country which is a contracting state to the EPC, joining Norway, Switzerland and Turkey. The EPO Boards of Appeal are the first and final judicial

STOP PRESS: This Practice Note is being updated to reflect the impact of reforms and developments related to the UK voluntary and statutory schemes for branded medicines. In particular, this Practice Note will have further discussion of the practical considerations and industry views of the consultation on the statutory scheme that closed in April 2025, the ongoing 2024 Voluntary scheme for branded medicines pricing, access and growth (VPAG) commitment and the updated commercial framework for new medicines and its related consultations. In the meantime, to follow the progress and discussion of these events, please see: Life sciences tracker—UK — Government initiatives and proposed reforms and its Consultations section. This Practice Note explores the rules relating to the pricing and reimbursement of medicinal products and medical devices in the UK. First, it introduces the current European regulatory framework for the pricing and reimbursement of medicinal products before setting out the position in the UK, including health technology assessments by the National Institute for Health and Care Excellence (NICE), the voluntary Pharmaceutical Price Regulation Scheme,

Pharmaceutical trade marks: regulation and naming procedures In most fields of business, trade mark owners have a relatively free hand in selecting the brands they use to market their goods or services. In general, where there is no risk of confusion on the part of the relevant consumer with an earlier brand, a trade mark will be free for use. This is not the case with respect to trade marks for pharmaceutical products, which are subject to an extra layer of regulation in order to protect public health. Pharmaceutical trade marks can only be put into commercial use once they have been granted a marketing authorisation (MA). In determining whether to grant an MA, the competent authorities will decide whether the trade mark poses a risk to public health. This decision is not reached through a classical trade mark infringement assessment, but instead centres on the potential for medication errors which could lead to serious health risks. The various considerations applicable to pharmaceutical trade marks will impact in different ways

A pharmacist has been sentenced to 28 months in prison for supplying regulated substances to the black market. Jasper Ojela, who owned a pharmacy in Dudley, was found to have supplied Class B and Class C controlled drugs with a total estimated street value of £280,490 to criminal associates. The Medicines and Healthcare products Regulatory Authority, which brought the case against Ojela, has also taken court action to recover the proceeds of their offending.

Pharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product throughout their use in patients. Before medicinal products are authorised for use, information regarding their safety and efficacy is obtained from clinical trials. It is essential, however, that safety continues to be monitored throughout patient use because post-authorisation medicinal products will typically be used in a larger number of patients, for a longer period of time and in combination with other medicinal products, meaning that adverse effects may occur that were not apparent during clinical trials. Consequently, EU law requires marketing authorisation holders (MAH), the European Medicines Agency (EMA), and national competent authorities (ie the medicines regulatory authorities in EU Member States) to operate a pharmacovigilance system. Following Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone regulatory authority. The overall EU pharmacovigilance system operates through co-operation between EU Member States, the EMA and the

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

A reference of an offer or possible offer to the chair of the CMA for the constitution of a group under Schedule 4 to the Enterprise and Regulatory Reform Act 2013.

Proceedings initiated by the European Commission under Regulation (EC) 139/2004, Article 6(1)(c) in respect of an offer or possible offer.

1. What is the applicable legislation? The key legislation relating to foreign direct investment (FDI) in the Philippines includes: • Republic Act (RA) No. 7042, as amended by RA No. 11647, also known as the Foreign Investment Act 1991 (FIA), and the Implementing Rules and Regulations (IRR) of the FIA which is the principal legislation regulating foreign investments in the Philippines. The FIA is intended to regulate and promote the State’s policy of productive foreign investment in activities which significantly contribute to sustainable, inclusive, resilient, and innovative economic growth, productivity, global competitiveness, employment creation, technological advancement, and countrywide development to the extent that foreign investment is allowed in such activity by the Constitution and relevant laws, and consistent with the protection of national security. RA No. 11647 is an amendment that aims to further this policy by allowing international investors to set up and fully own domestic enterprises in the Philippines • The 1987 Constitution of the Republic of the Philippines (Constitution), specifically Article XII (National Economy and Patrimony), which provides guidance on the grant of rights,