The European Commission published the proposed European Biotech Act on December 16, 2025, focusing on innovative development in the health biotech sector. It aims to strengthen the competitiveness of the EU's biotech industry and accelerate the translation of innovative achievements into practical applications. This proposal holds significant reference value for the preparation and application of biotech patents.
To incentivize the development of innovative biotechs and address the industry-wide challenge of the "disconnect between patent protection periods and marketing authorisation timelines" for biotechnological medicinal products, the proposal suggests that pharmaceutical companies may extend Supplementary Protection Certificates (SPCs). The holder of an SPC is entitled to a 12-month extension of the protection periods referred to in Article 13(1) and (2) of Regulation (EC) No 469/2009 of the Council of the European Union.
To qualify for this SPC extension, the following conditions must be met:
The medicinal product contains a new active substance distinctly different from that of any authorised medicinal product in the Union;
The medicinal product has a mechanism of action distinctly different and shows a level of safety and efficacy which is at least equivalent to that of any authorised medicinal product in the Union for the same disease;
The clinical trials for the medicinal product were conducted in more than two Member States of the European Union;
At least one manufacturing step (excluding packaging, quality testing and certification) is performed in the Union.
To speed up the market entry of innovative achievements in health biotechnology and reduce the time costs for enterprises to bring innovations to fruition, the European Commission simultaneously proposes to streamline regulatory procedures and shorten clinical trial authorisation timelines, thereby accelerating the commercial translation of intellectual property. The proposal introduces corresponding amendments to Regulation (EU) No 536/2014, including the following key adjustments:
The authorisation timeline for multinational clinical trials will be shortened from 106 days to 75 days (including validation and ethical review);
The additional 50-day assessment period for Advanced Therapy Medicinal Products (ATMPs) will be eliminated;
The assessment period for substantial modifications to clinical trials will be reduced from 96 days to 47 days.
Furthermore, the EU will establish an "EU Health Biotechnology Support Network". It aims to assist developers of biotech products and projects in identifying the applicable rules and identifying opportunities, thereby fostering the biotech innovation ecosystem.
The network will specifically provide the following information services and support:
Information on the national and Union rules applicable to the development and placing on the market of health biotech products, including applicable authorisation procedures;
Information for the identification and use of applicable regulatory frameworks and regulatory support mechanisms for innovative health biotech products;
Information and support for project promoters regarding intellectual property procedures and technology transfer.
This proposal provides robust institutional safeguards for innovators in the biotech field. And it is designed to consolidate and enhance the EU's core competitiveness in the global health biotech sector.
For more details, please see the original text: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations.
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