European courts and regulators target the intersection of regulatory and patent trends in the life sciences

The European lifecycle of an innovative medicine rests on two interlocking pillars: the regulatory exclusivities around marketing authorisations (data exclusivity and market protection) and intellectual property (IP) rights (patent and supplementary protection certificate (SPC)). The regulatory framework sets out the earliest lawful entry point, while the patent and SPC status determines whether and how quickly competition actually arrives. These IP rights may be used as a tool to take over from such regulatory protection and to try to prevent generic drug manufacturers from entering the market.

The case of Biogen’s Tecfidera (dimethyl fumarate) illustrates how those regimes are intertwined in practice. On 24 September 2025, the EU General Court handed down a judgment (T-256/23) clarifying the strict requirements for the extra year of market protection under article 14(11) of Regulation 726/2004, while multiple preliminary injunction (PI) battles across Europe and opposition proceedings running in parallel before the European Patent Office (EPO) probed the robustness of the formulation-dose patent EP 2 653 873 (EP 873) covering the same product.

This case has a particular resonance in a context of the revision of the EU “Pharma Package” and the increasing case law developments of the Unified Patent Court (UPC) in the life sciences sector.

Tecfidera market protection

Under the current regime of Regulation No 726/2004, two sets of regulatory timeframes apply to the protection of a medicinal product: eight years of data protection, granting exclusive rights to data from pre-clinical tests and clinical trials, and two years of market exclusivity, granting the exclusive right to sell a product without immediate competition from generic medicines or biosimilars. Under article 14(11) of the regulation, this 10-year period may be extended by a maximum of one year – hence the "8+2+1" rule – provided that the marketing authorisation (MA) holder obtains an authorisation for one or more new therapeutic indications during the first eight years of the original MA. Such indications must be held to bring a significant clinical benefit in comparison with existing therapies. In other words, obtaining that new authorisation is a necessary prerequisite for the grant of an additional year of market protection, thereby extending the total protection period from ten to eleven years.

Biogen obtained the MA for Tecfidera on 30 January 2014 (notified on 3 February 2014), whereas the European Commission decision granting authorisation for the new therapeutic indication was issued on 13 May 2022, more than three months after the expiry of the first eight years of the marketing authorisation on 2 February 2022.

In its judgment T-256/23 of 24 September 2025, the General Court annulled the Commission's decision C(2023) 3067 (final), which had granted Biogen an additional year of market protection for Tecfidera until 2 February 2025. The General Court keeps a strict time gate for the +1 year and ruled that the requirements of article 14(11) of the regulation must be strictly complied with. The one-year extension rule is designed to strike a balance between two complementary objectives: promoting research into new therapeutic indications with significant clinical benefit, and facilitating the production of generic medicinal products.

Accordingly, the Commission could not rely on the allegedly particular circumstances of the case, its factual complexity, or the intervening litigation brought by third-party generic manufacturers against the 2014 implementing decision for Tecfidera's MA. Article 14(11) imposes hard deadlines over which the Commission enjoys no discretion.

An appeal has been lodged against the General Court's decision and is currently pending before the Court of Justice of the European Union.

The Hamburg Regional Court as separately confirmed that the grant of a marketing authorisation for generic drugs does not exclude liability on the part of the generic manufacturers if they enter the market before the expiry of the market protection period. Such conduct was found to amount to negligence, and the Court accordingly ruled that Biogen is entitled to damages.

Tecfidera patent disputes

When a patent or SPC covering a pharmaceutical product approaches expiry, right holders tend to enforce their exclusive rights against generic companies that have begun preparing to launch on the market. A PI is typically sought by the manufacturer of the reference medicinal product (the patentee) to challenge preparatory acts taken by the generic companies that may qualify as acts of infringement or, more specifically, a risk of imminent infringement.

The Tecfidera case illustrates the interconnection between regulatory and IP matters. The dosing basis of Tecfidera was also covered by European patent EP 873, filed under a priority date of 8 February 2007, and claiming a composition comprising dimethyl fumarate or monomethyl fumarate with excipients administered at a 480 mg daily dose. EP 873 was opted out from the competence of the UPC in May 2023.

Although opposition proceedings were filed by 14 opponents at the EPO against EP 873, the patent owner turned to national courts before the expiry of Tecfidera's market protection on 2 February 2025 to seek PIs against generics in France, Germany and the Netherlands. Notwithstanding the EPO Opposition Division (OD) having upheld EP 873 in an amended form on 11 December 2024, the courts in all three countries dismissed the PI applications due to serious doubts over the prima facie validity of EP 873, particularly for lack of inventive step. For instance, in France in the proceedings against Teva, the presiding judge at the Paris Court ruled on 3 February 2025 (RG 24/58777) that the EPO's lengthy reasoning on lack of inventive step remained cogent, on the basis that the person skilled in the art was incentivised to seek an alternative to the 720 mg/day dose given the adverse effects identified in clinical trial results published before the priority date, making the solution obvious.

Numerous opponents appealed the OD decision. The Board of Appeal heard the case in late November 2025 (T 1462/24) and decided to reverse the first instance decision and revoke EP 873 for added matter, bringing the various proceedings in France, Germany and the Netherlands to a definitive end.

Pharma Package reform

The different timeframes for regulatory and IP protection in the life sciences sector are among the most contested issues of the Pharma Package currently being debated at EU level. The purpose of this reform is to strike a balance between providing incentives for originator companies and ensuring rapid patient access to innovative medicines, while generating savings for social security systems and fostering the market for generic, hybrid and biosimilar products. In December 2025, the Council and the European Parliament reached a provisional agreement.

While earlier proposals from the Commission and Parliament had sought to reduce the MA data protection period, the provisional agreement retains the current eight-year period, with an additional year available by way of a "transferable data exclusivity voucher" awarded for priority antimicrobials. As regards market protection, the initial period is set at one year, with a further one-year extension available for new indications (provided that the MA holder obtains such authorisation during the regulatory data protection period, as in the Biogen case), giving a revised "8+1+1" structure. The agreement also preserves multiple exceptions allowing the regulatory market protection period to be extended by an additional year; for instance, where a medicinal product meets an unmet medical need or has undergone comparative clinical trials. This caps total possible regulatory protection at eleven years, making the rule effectively "8+1+(1)+1".

The marketing exclusivity period for orphan drugs has also been revised. While the current regime provides for 10 years of market exclusivity, the new framework will apply as follows: nine years as the general rule, 11 years where there is an unmet medical need, and four years where the MA is granted on the basis of well-established medicinal use of the active substance.

The Pharma Package also addresses IP rights. The scope of the "Bolar exemption" has been significantly broadened. The exemption allows manufacturers to take the steps necessary, such as studies or trials, to ensure that generic or biosimilar versions of a medicine can be placed on the market on "day one" following the expiry of IP rights (patent or SPC).

The expanded scope now encompasses:

• obtaining an MA for generic, biosimilar, hybrid or bio-hybrid medicinal products and subsequent variations, which is a purely administrative act and an approach the UPC has adopted consistently
• conducting health technology assessments
• obtaining pricing and reimbursement (P&R) approval
• and most significantly, submitting procurement tender applications, provided that this does not entail sale, offer for sale or marketing.

It remains to be seen how courts will assess what constitutes a reasonable timeframe before "day one" within which these acts may begin to be performed without constituting imminent infringement or being fully completed.

The provisional agreement must now be formally endorsed by both the Council of the European Union and the European Parliament before being formally adopted, potentially later this autumn, and will enter into force upon publication in the EU's Official Journal, with a two-year transitional period thereafter.

UPC, life sciences and PIs

The Tecfidera case also illustrates the latest trends in the life sciences sector before the UPC.

Since the UPC became operational, approximately 67 decisions have been issued on provisional measures filed before it, around 70% in inter partes applications. More than half involving the life sciences sector, making it the most active area before the court, followed by the technology industry.

Under article 62.4 of the UPC Agreement and Rules 206 and 211.2 of the Rules of Procedure (RoP), the UPC applies a "sufficient degree of certainty" standard to the validity and alleged infringement of the patent at issue, which remain the two principal grounds for refusing provisional measures, before considering whether there has been an unreasonable delay or weighing the balance of interests. PIs are an emerging trend for the UPC in the life sciences sector.

As regards infringement in the pharmaceutical context, the emerging UPC case law demonstrates that the "imminent infringement" requirement must be assessed on a case-by-case basis and in light of national laws and regulations; an exercise requiring both IP and regulatory expertise of local teams for each relevant market. Applying a "set the stage" test, the UPC has ruled that the mere application for or grant of an MA does not amount to imminent infringement; however, the completion of national health technology assessment and pricing and reimbursement procedures may constitute relevant facts.

In the Boehringer v. Zentiva case, the UPC Court of Appeal ruled that the defendant was in a position to offer its generics to public hospitals and participate in public procurement without any further administrative steps or procedures (13 August 2025, UPC CoA 446/2025). In the field of medical devices, the UPC also found that a defendant had "set the stage" for marketing by obtaining and publicly announcing CE-mark approval for the disputed products, providing "ordering information" and announcing plans to showcase the products at a trade fair (21 October 2025, UPC CFI 553/2025).

Osborne Clarke comment

Claimants will need to pay close attention to the urgency requirement when applying for provisional measures and actively monitor the market for any sign of an imminent launch at risk. The unreasonable delay period begins only when the applicant knows or ought to have known all the relevant evidence necessary to file the PI application under Rule 206.2 RoP (27 April 2026, UPC CoA 917/2025). 

Defendants intending to launch their product on day one will also want to carefully review their preparatory acts and refine their market communications. Where there is exposure to risk, filing a protective letter under Rule 207 RoP is a recommended means of guarding against a potential ex parte provisional measure application before the UPC, which may explain why only a small number of PIs have been granted on an ex parte basis.

Our life sciences experts and UPC representatives at Osborne Clarke are ready to assist you in navigating these complex strategies.