The EU Pharmaceutical Legislation: Why Regulatory Reform Matters for IP Teams

The forthcoming EU General Pharmaceutical Legislation (GPL) is expected to be the most significant overhaul of the EU medicines framework in more than 20 years. Debate has focused on core regulatory questions such as shorter baseline protection, revised orphan incentives and new obligations intended to improve patient access. For intellectual property teams, however, the new legislation is equally important because it will reshape the relationship between regulatory protections, patents and supplementary protection certificates (SPCs).

The change is not simply that some regulatory protection periods may be shorter. Protection will also become more conditional and variable: development strategy, comparator-trial design, the location of clinical studies, the sequence of global regulatory filings, launch planning and post-authorisation conduct may all affect the protection available. Patent and regulatory strategy will therefore need to be coordinated much earlier in the product lifecycle so companies can understand and plan for these variables.

On the current timetable, the legislation is expected to be voted on and to enter into force by the end of 2026 and, under the transition provisions, will in general apply to products for which marketing authorisation applications are made after the end of 2028. Products already in development may therefore fall within the new regime, so companies should review portfolios and lifecycle plans now. We set out below some key areas that may impact patent teams.

A MORE VARIABLE REGULATORY PROTECTION FRAMEWORK

Innovative medicines currently receive eight years of regulatory data protection, followed by two years of market protection plus, potentially, a further year of market protection for authorisation of a new therapeutic indication. Although complex, this framework provides a reasonably predictable baseline for planning patent expiry and SPC protection. Under the new GPL, these protection periods will change.

Regulatory Protection Periods Are Likely to Be Shorter and More Variable

The GPL retains eight years of data protection but reduces standard market protection to one year. Additional periods may be available for meeting specified conditions, including addressing an unmet medical need, conducting comparator trials in accordance with scientific advice, undertaking broader EU clinical development and filing in the EU within 90 days of filing in other jurisdictions.

Intellectual property (IP) teams will therefore need to model several possible outcomes that may change as clinical and commercial decisions evolve. They should also consider whether patent filings can be aligned with development choices that qualify for additional protection, including programmes directed at an unmet medical need.

The Orphan Protection Period Is Likely to Be Shorter with a Single ‘Global Orphan Marketing Authorisation’ for All Indications

Baseline orphan exclusivity will fall from 10 years to nine, while a new class of “breakthrough” orphan products may receive 11 years. The definition of a breakthrough product, the data needed to meet this definition, and how the regulators interpret it in practice, will be critical for obtaining this additional period of protection.

The GPL also introduces a single global orphan marketing authorisation concept, covering all orphan conditions for a product, replacing the current position of successive protection periods for separate indications in new conditions. Changes to when applications for similar products, including generics, may be submitted during the exclusivity period could further reduce its practical effect.

For developers pursuing several orphan indications, the regulatory clock will no longer restart with each designation. Stronger patent protection for individual indications, dosing regimens, formulations and treatment methods may take on greater significance, with patent and SPC strategies aligned more closely to the timing of each development programme.

Supply Obligations May Reshape Development and Launch Planning

Individual member states may require marketing authorisation holders benefiting from the new regulatory or orphan protection periods to launch the product and maintain supply in a given member state. Failure to comply could lead to a loss of market protection, or any orphan extension, in the member state concerned.

Although intended to improve access, these obligations may limit companies’ flexibility around launch sequencing, which is often driven by pricing, reimbursement or wider commercial considerations, and could lead to different protection periods across the EU. If exclusivity is lost in a (smaller) market, patents and SPCs may become the principal protections and assume greater importance than in (larger) markets where regulatory protection remains. The legislation also seeks to prevent parallel trade where a generic is able to launch earlier as a result of loss of protection in a given country, but this will require monitoring; patent rights should remain unaffected.

Paediatric Development May Lead to an Extension to the SPC, but Not the Orphan Exclusivity Period

Paediatric development will be rewarded differently compared to the current regime. Currently, a product can obtain a reward for completion of paediatric studies of an extension to the SPC. However, if the product is an orphan product, that reward is instead an extension to the orphan protection period.

Under the GPL, completion of relevant studies for an orphan medicinal product will no longer attract an additional two years of orphan exclusivity, and instead, only the six-month SPC extension will be possible, regardless of the product type. Under the current rules, while some companies have removed orphan designation to pursue the SPC extension, the orphan extension has been important for others; under the GPL, this will no longer be an option.

Patent offices will continue to determine SPC and paediatric extensions after the relevant regulatory steps have been taken, requiring continued coordination between patent and IP teams. The proposed single examination procedure for SPCs across the Unified Patent Court (UPC) territory may also alter the optimal strategy.

Additional Data Protection Will Be Available for Repurposed Products

The GPL introduces four years of data protection for a new therapeutic indication of an established medicine that has not previously been authorised in the EU, provided adequate clinical and, where appropriate non-clinical, studies demonstrate significant clinical benefit. The incentive is available where the product is authorised as a generic that has not previously received data protection, or where at least 25 years have passed since the initial marketing authorisation. Composition-of-matter patents for products of that age will usually have expired, but the ability to obtain other patents should still be assessed. The incentive offers another lifecycle-management tool and reinforces the need for coordinated regulatory and IP analysis.

Overall, regulatory protection will depend increasingly on strategic development and launch decisions rather than solely on the product’s characteristics, so the extent of protection may remain uncertain until late in development. Robust portfolios, including SPCs, formulation, manufacturing and second-medical-use patents, may therefore play a greater role in determining the expected loss-of-exclusivity date.

OTHER IMPORTANT CHANGES THAT PATENT TEAMS SHOULD BE AWARE OF

While the changes to the protection periods may have received the most attention, there are other important points that may impact patent and IP strategies and may require greater coordination between regulatory and IP teams at the end of the product lifecycle. For example:

Generic Skinny Labelling and Interchangeability for Biosimilars

Regulators are increasingly accepting generic carve-outs that remove patent-protected information beyond “indications or dosage forms” that are listed in the legislation. The GPL appears to codify this broader approach by permitting deletion of information concerning posology, pharmaceutical form, methods or routes of administration and other patented aspects of product use. This gives generic and biosimilar manufacturers a clearer route to distinguish non-infringing uses, although its effect on infringement findings remains uncertain.

The legislation also states that biosimilars are comparable with their reference products in efficacy, safety and immunogenicity and are therefore interchangeable. This supports faster competition after IP and regulatory protections expire, but it is unclear whether a skinny-labelled biosimilar can be treated as interchangeable with a full-label reference product while rights remain in force.

The answer is likely to depend on developing national and UPC jurisprudence. The UPC has taken a holistic approach, considering product information alongside the wider market, prescribing practice and whether infringing use is foreseeable. In contrast, some national courts may give the authorised label greater weight, making a country-by-country analysis advisable.

The Expanded Bolar Exemption

The Bolar exemption currently protects certain activities, including clinical testing for follow-on products, from patent infringement. The GPL will extend it to activities supporting health technology assessment, pricing and reimbursement, procurement and third parties in the supply chain.

While intended to remove barriers to generic entry, the expansion raises enforcement questions. Innovators will need to reconsider the timing of infringement proceedings and preliminary injunction applications, particularly where tenders are involved. Recent UPC decisions have begun to address the boundary, but uncertainty will remain until national courts and the UPC interpret the new provisions. The injunction window may narrow as courts decide which preparatory acts amount to an imminent threat, and it remains unclear whether trials conducted for marketing approval outside the EU are exempt.

WHAT PATENT TEAMS SHOULD CONSIDER

Patent and regulatory functions have often operated in parallel, coming together mainly for an SPC application or extension. Under the GPL, this alignment may need to begin earlier. Clinical trial design, study location and the sequence of global regulatory filings may affect regulatory rewards while also influencing filing strategy, patent term management and freedom-to-operate analysis. Decisions on new indications, paediatric programmes, launch sequencing and commercialisation should be assessed through both regulatory and IP lenses.

At the other end of the lifecycle, where protection is lost in an individual member state, patents may become the main defence against generic or biosimilar entry; local filings, SPC strategy and enforcement planning should therefore be considered alongside country-specific launch and supply plans. There may also be additional considerations around generic entry, relating to skinny labels and the expanded Bolar exemption, which will need to be considered by both teams.

The United Kingdom adds a further layer. The UK government has stated its intention to maintain the current protection periods, so its regulatory protection periods will remain longer and more predictable than those under the new EU framework. The post-Brexit authorisation system is already complex: some products continue to be authorised under UK law together with applicable EU law, while others, including medicines formerly within the mandatory or voluntary scope of the EU centralised procedure, are regulated under UK law. The GPL will deepen EU-UK divergence and complicate portfolio and launch planning.

PREPARING FOR THE NEW LANDSCAPE

Many marketed products will remain under the existing regime, but applications filed after the end of 2028 will be governed by the GPL. IP teams should reassess portfolios, orphan and follow-on indication strategies, launch sequencing and supply commitments, while considering how broader label carve-outs and the expanded Bolar exemption may affect enforcement.

Our life sciences team is working with patent and regulatory teams to navigate these changes and will continue to monitor the legislation as it is finalised and implemented.