This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.

On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech sector and accelerating the development and availability of groundbreaking treatments. One key incentive under the Proposed Regulation would encourage the development of innovative biotechnology medicines, and subsequent manufacturing within the EU, by offering innovators a potential 12-month extension of their SPCs, subject to specific conditions being met.

Under the current SPC Regulation (EC) No 469/2009 (“SPC Regulation”), a patent holder may be able to obtain an SPC that grants the patent holder additional patent protection rights for a qualifying medicine for up to five years where there is a delay between the date of filing of the patent and the grant of the marketing authorization for the medicine. The period of protection may also be subject to a possible six-month extension under the Pediatric Regulation 1901/2006/EC upon successful completion of an agreed pediatric investigation plan.

Under the Proposed Regulation, patent holders could benefit from a further 12-month extension of SPC protection for an advanced therapy medicinal product (“ATMP”) or any medicinal product developed using biotechnology processes, provided they satisfy all of the following conditions:

  1. The medicine contains a new active substance “distinctly different” from any active substance previously approved in the EU.
  2. The medicine has a “distinctly different” mechanism of action and demonstrates at least equivalent safety and efficacy compared to any approved medicine in the EU for the same disease.
  3. Clinical trials conducted to evaluate the medicine’s efficacy and submitted as part of the EU marketing authorization application were carried out in more than two EU Member States.
  4. At least one manufacturing step for the medicine (excluding packaging, quality testing, and certification) must be performed within the EU.

The European Medicines Agency (“EMA”) will be the authority responsible for assessing whether these criteria are satisfied. The Proposed Regulation also includes a similar provision to grant a 12-month SPC extension for qualifying innovative veterinary medicines intended to diagnose, treat, or prevent zoonotic diseases.

For now, we will have to wait to see how the proposal is received during its consideration by the European Parliament and the Council as part of the legislative process. There is likely to be significant hostility to the proposal from the generic and biosimilar industries. One initial question arising from the current wording is how the term “distinctly different” will be interpreted and assessed in practice by the EMA, if adopted into law.

This blog is based on the wording of the EU’s proposal published on 16 December 2025. This wording may significantly change during the legislative process. Our European Life Sciences team will continue to monitor developments. Please feel free to reach out to the team with any questions.

Photo of Grant Castle Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
Advertising and promotion of both pharmaceuticals and medical devices; and
Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

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Photo of Inga-Marlene Pietsch Inga-Marlene Pietsch

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets.  She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive…

Inga-Marlene Pietsch is an intellectual property lawyer in Covington’s Life Sciences Transactions team assisting clients in protecting and enforcing their most valuable assets.  She works closely with other teams across the firm in particular the Corporate and Regulatory teams.

Inga has an extensive contentious and non-contentious IP practice advising companies from the Life Sciences and Technology sectors on complex IP issues with a particular focus on patents. Her previous experience in patent litigation gives Inga a unique perspective on IP issues that arise.

Inga’s clients include start-up companies as well as large corporations advising throughout the company life cycle.

Inga regularly advises clients on:

IP aspects in transactions
IP strategy and landscaping
Third party IP risk assessments
IP ownership and entitlement
IP validity assessments
Cross-border IP issues
Supplementary Protection Certificates

Inga also advises clients on managing and protecting their trade secrets and confidential information, assisting clients in auditing and identifying their trade secrets and putting procedures and processes in place to establish good trade secrets and confidential information handling practices.

Prior to her legal career Inga completed a Ph.D. in Organic Chemistry and worked for a custom synthesis start-up company.

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Photo of Roderick Dirkzwager Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a…

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
regulatory and commercial due diligence for life sciences transactions; and
intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington’s Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

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