Section 24 Patg (2026), Compulsory Licensing for Pharmaceutical Patents in Germany

Compulsory licensing germany pharma remains one of the most consequential, and most misunderstood, areas of patent risk for originators and generics operating in the German market. Section 24 of the German Patent Act (Patentgesetz, PatG) allows the Federal Patent Court to grant a compulsory licence to a patented invention where the public interest demands it and the applicant has, within a reasonable period and on reasonable commercial terms, unsuccessfully sought the patentee’s consent. Renewed regulatory attention to supply-chain resilience, medicine shortages and public-health exceptions since 2020 has put compulsory licensing germany pharma firmly back on the strategic agenda for 2026.

This article provides a statute-led, practice-oriented explanation of how §24 PatG works, who may apply, what must be proven, and how originators and generics should prepare. For readers seeking local counsel, our Pharmaceutical practice area, Germany pages collate practitioners experienced in these disputes.

Executive summary: what §24 PatG does and why it matters in 2026

Section 24 PatG is the statutory mechanism by which a third party may obtain the right to work a patented invention without the patentee’s consent, in exchange for adequate remuneration, where the public interest requires it. It is an exceptional remedy, not a routine licensing route, and the threshold is deliberately high, compulsory licences have been granted only rarely in German practice.

• Eligibility. A compulsory licence may be granted where the applicant has, within a reasonable period, sought a licence on reasonable commercial terms and been unsuccessful, and where the public interest requires the grant.
• Procedure. Applications are decided by the Bundespatentgericht (Federal Patent Court), with appeal to the Bundesgerichtshof (Federal Court of Justice, BGH). A preliminary compulsory licence may be available in urgent cases under §85 PatG.
• Immediate risk for originators and generics. For originators, the risk is a limited loss of exclusivity where a product is deemed essential and the public interest justifies access; for generics and other applicants, the opportunity lies in securing lawful access to a blocked market where public health justifies it.

The practical lesson of compulsory licensing germany pharma is that both sides should prepare early: evidence of good-faith licensing negotiations, documented supply conditions and a clear public-interest narrative frequently decide the outcome long before any hearing.

Statutory text and plain-English translation of section 24 PatG

The governing provision is set out in Section 24 PatG, published in the official consolidated version maintained by the Federal Ministry of Justice. In essence, the provision establishes two cumulative conditions that must be satisfied before a non-exclusive compulsory licence may be granted: the unsuccessful pursuit of a voluntary licence on reasonable terms within a reasonable period, and an overriding public interest in the grant.

In plain English, §24 PatG provides that the Federal Patent Court may grant a non-exclusive authorisation to commercially use an invention where the applicant has unsuccessfully endeavoured, within a reasonable period and on reasonable commercial terms, to obtain the patentee’s consent, and where the public interest calls for the grant of the compulsory licence. The statute further addresses the situation of dependent patents and certain plant and biotechnological inventions, and confirms that the patentee is entitled to appropriate remuneration determined with regard to the circumstances of the case.

Crucially, the provision situates compulsory licensing within the broader architecture of the Patent Act, which defines the scope of patent rights, the exceptions to infringement, and the jurisdiction of the specialist patent courts. Reading §24 PatG in isolation is a common error; its thresholds only make sense against the backdrop of the Act’s definitions of working, exploitation and the rights conferred by a patent.

Scope: patents versus SPCs

Section 24 PatG applies to national patents and to the German national parts of European patents, which, once granted, are enforced as national rights under the Patent Act. Supplementary protection certificates (SPCs), which extend protection for certain medicinal and plant-protection products beyond the patent term, raise distinct questions. Because an SPC confers rights derived from, but separate to, the basic patent, any compulsory-licensing analysis that touches an SPC-protected product should treat the SPC layer explicitly rather than assuming the §24 PatG analysis simply carries across. The regulatory exclusivity attaching to marketing authorisations adds a further, independent layer that a compulsory licence alone does not dissolve.

Legal grounds: public interest, non-working and health

The central ground under §24 PatG is public interest, a flexible but demanding standard. In the pharmaceutical context, public interest typically crystallises around the availability of an essential medicine, the adequacy of supply to patients, and the absence of a therapeutic alternative. Related grounds, including the licensing of a dependent improvement patent, feed into the same assessment. The public-health dimension is central: the more clearly an applicant can demonstrate that patients are harmed by a lack of access and that no reasonable alternative exists, the stronger the public-interest case becomes.

Who can apply and what must be shown (procedural standing)

Standing to pursue compulsory licensing germany pharma is broader than many assume but is tightly conditioned by the statute. A private third party, typically a competitor, generic manufacturer or supplier seeking to work the invention, may apply. The applicant must come to the court with a concrete, bona fide intention to exploit the invention, not a tactical application designed solely to pressure the patentee.

Before any application can succeed, the applicant must ordinarily establish two procedural prerequisites. First, it must show that it genuinely sought a voluntary licence from the patentee within a reasonable period and offered reasonable commercial terms. Second, it must show that the patentee refused, or failed to engage meaningfully with, that request. These prerequisites are not mere formalities: the quality and documentation of the pre-litigation correspondence frequently determine whether the court treats the statutory threshold as crossed. A superficial, last-minute licensing enquiry is unlikely to satisfy the “reasonable endeavours” requirement.

Evidence required: supply shortage, non-working and licensing refusal

The evidentiary burden on an applicant for a compulsory licence patent germany action is substantial. Applicants are expected to assemble and present:

• Documented licensing attempts. Correspondence demonstrating a genuine, timely request for a licence on reasonable terms, and the patentee’s refusal or non-engagement.
• Evidence of public interest. Clinical, epidemiological or supply data showing that patients face a shortage, that the product is medically necessary, and that no adequate therapeutic alternative exists.
• Proof of capability. Evidence that the applicant can actually manufacture or supply the product to the quality and quantity required, including regulatory readiness and manufacturing capacity.
• Market and pricing data. Information bearing on the reasonableness of the terms offered and on the remuneration that would be appropriate if a licence is granted.

Because the patentee will contest each of these points, applicants should prepare their evidentiary record as though for a full merits hearing from the outset. Conversely, originators defending a §24 PatG application should scrutinise each strand of the applicant’s evidence, particularly the adequacy of its licensing approach and the genuineness of any asserted shortage.

Procedure and timeline: filing, DPMA and BPatG involvement, appeal routes

The procedural architecture for compulsory licensing germany pharma centres on the Federal Patent Court, with the Deutsches Patent- und Markenamt (DPMA) providing official administrative information on the German patent system. A §24 PatG compulsory-licence action is not an application to the patent office but a court action brought directly before the Bundespatentgericht (Federal Patent Court).

The typical flow of a compulsory licence patent germany action can be summarised as follows:

1. Pre-action licensing phase. The prospective applicant approaches the patentee, requests a licence on reasonable terms, and documents the response. This phase establishes the statutory precondition.
2. Filing the action. The applicant files a compulsory-licence action with the Federal Patent Court, setting out the public interest and the failed licensing negotiations, supported by evidence.
3. Procedural and evidentiary review. The court examines standing, the statutory preconditions and the public-interest case, typically with written submissions, expert evidence and an oral hearing.
4. Decision and licence terms. If the court grants the licence, it defines the scope, duration, field of use and the remuneration payable to the patentee.
5. Appeal. The decision may be appealed to the Federal Court of Justice (BGH).
6. Enforcement. Once final, the licence is enforceable, and the licensee may work the invention within the ordered scope on payment of the fixed remuneration.

The illustrative timeline below reflects the practical reality that final compulsory-licence proceedings are substantive and can run for many months, while preliminary relief, where available, is designed to operate far more quickly.

Timeline illustration, indicative stages in a §24 PatG compulsory licensing germany pharma action. Durations vary with complexity, evidence and urgency.

Emergency and preliminary compulsory licences, process and evidentiary threshold

Where delay would cause serious harm, for example, an imminent and unaddressed shortage of an essential medicine, §85 PatG allows the Federal Patent Court to grant a preliminary (interim) compulsory licence by way of an injunction pending the final decision. The hallmark of preliminary relief is urgency: the applicant must demonstrate that immediate access is necessary and that the balance of interests favours interim intervention. The evidentiary emphasis shifts from an exhaustive demonstration of the merits towards a showing of immediacy and proportionality. Because interim relief can have a dramatic commercial effect, courts weigh the patentee’s interests carefully, and the applicant bears a significant responsibility to justify the urgency.

A preliminary compulsory licence is, by design, provisional: it persists only until the final decision resolves the matter definitively.

Remedies, scope of licence and limitations

A compulsory licence under §24 PatG is not a general dispossession of the patent. It is a carefully bounded authorisation, and the statutory design constrains it in several ways. The licence is non-exclusive, meaning the patentee retains the right to exploit the invention and to grant other licences. It is also limited to what the public interest actually requires: the court tailors the scope, field of use, territory and duration so that the intrusion on the patentee’s rights goes no further than necessary to meet the identified need.

The patentee retains important rights throughout. It is entitled to adequate remuneration, it may appeal the decision, and it continues to own and enforce the patent against unauthorised uses falling outside the licence. The compulsory licence does not extinguish the patent; it carves out a defined, remunerated right of use. Where circumstances change, for example, if the public-interest justification falls away, the licence may be withdrawn or its terms revisited on application, providing a safety valve.

Calculation of remuneration, benchmarks and practical negotiation tips

Remuneration under a compulsory licence is intended to be adequate compensation to the patentee, reflecting the economic value of the licence rather than a penal or nominal figure. In practice, courts and parties look to customary licence fees for comparable technologies, the royalty rates the patentee has agreed in arm’s-length deals, and the specific market conditions for the product. The public-interest character of the licence informs, but does not eliminate, this commercial assessment; the aim is fair value, not expropriation.

Practically, both sides benefit from building a remuneration case early. Patentees should maintain a defensible record of their own licensing benchmarks and comparable-deal royalties, since these will anchor any remuneration debate. Applicants should model the economics of the product and be prepared to justify why their proposed rate is reasonable. Because the court’s remuneration determination draws on the same market evidence that informs the pre-action licensing negotiations, a well-prepared party can often shape the outcome before a figure is ever ordered.

Interaction with other IP rights and public health law

Compulsory licensing germany pharma never operates in a vacuum. A pharmaceutical product is typically protected by a layered set of rights and regulatory exclusivities, and a compulsory licence over the basic patent addresses only one layer. SPCs extend protection for authorised medicinal products beyond the patent term; because they are distinct rights, the practical effect of a compulsory licence on an SPC-protected product requires separate analysis rather than an assumption that the patent-level licence resolves everything.

Regulatory approvals add a further dimension. A compulsory licence confers the right to work the invention, but it does not, by itself, grant a marketing authorisation. A generic entrant relying on a compulsory licence must still hold or obtain the appropriate authorisation to place the product on the market. The interplay between patent rights and the broader European patent system is relevant too: for European patents, the framework and legal texts maintained by the European Patent Office govern grant and scope, while enforcement and compulsory licensing of the German national parts fall to the German courts.

At the international level, Germany’s compulsory-licensing regime operates within the constraints of Article 31 of the TRIPS Agreement, which permits use of a patented subject matter without the right-holder’s authorisation subject to conditions, including, in general, prior efforts to obtain a voluntary licence on reasonable commercial terms, a predominantly domestic-supply orientation, and adequate remuneration. The §24 PatG preconditions mirror these international requirements, which is why the public-interest and failed-negotiation elements are so central.

Litigation strategy for originators and generics (practical playbook)

The strategic playbook for compulsory licensing germany pharma differs sharply depending on which side of the dispute a company sits, but both sides win or lose on the quality of their evidence and the credibility of their public-interest narrative.

For originators defending against an application, the priorities are:

• Engage genuinely with licensing requests. A documented, good-faith response to any licence enquiry undermines the applicant’s claim that reasonable efforts were refused.
• Challenge the public-interest case. Marshal evidence that supply is adequate, that alternatives exist, or that the applicant cannot in fact deliver the product reliably.
• Prepare remuneration benchmarks. Keep comparable licence terms ready to shape any remuneration determination.
• Consider settlement. A negotiated voluntary licence on controlled terms may be preferable to a court-imposed compulsory licence with less favourable scope and rate.

For applicants, generics or suppliers, the priorities are:

• Document the licensing approach. Make a timely, reasonable request and preserve the correspondence that proves it.
• Build the public-interest record. Assemble shortage, clinical-need and no-alternative evidence before filing.
• Demonstrate capability. Show manufacturing and regulatory readiness so the court sees a credible route to actual supply.
• Assess interim relief. Where urgency is real, a preliminary compulsory licence under §85 PatG may deliver access far faster than final proceedings.

When to seek interim relief versus negotiating licence terms

Timing is often decisive. An applicant facing an acute, demonstrable shortage may be justified in seeking a preliminary compulsory licence, accepting the higher burden of showing urgency in exchange for rapid access. Where the need is real but not immediate, the better course is frequently to invest in the full merits case and a well-evidenced licensing approach, since a negotiated or final licence on considered terms tends to be more durable than emergency relief. For originators, the equivalent question is whether to litigate the public-interest threshold hard or to negotiate a voluntary licence that preserves control over scope, field and remuneration.

The likely practical effect of a credible compulsory-licence threat is to bring both parties to the negotiating table, which is often where the most workable outcomes are reached.

Risk checklist and compliance actions for compulsory licensing germany pharma

The following checklist translates the statutory and strategic analysis into concrete actions. It is designed for in-house teams managing compulsory licensing germany pharma exposure, whether defending exclusivity or planning entry.

• Conduct regular supply audits for products that could be deemed essential, and document continuity of supply.
• Map your German patent and SPC portfolio against your product pipeline to identify compulsory-licence exposure.
• Establish a protocol for responding promptly and reasonably to any inbound licence request, with full records.
• Maintain a file of comparable licence terms and royalty benchmarks to support any remuneration debate.
• Monitor medicine-shortage reporting and public-health signals relevant to your therapeutic areas.
• Assess regulatory exclusivity and marketing-authorisation status separately from patent status for each key product.
• Prepare regulatory contingency plans, including how a compulsory licence would interact with authorisation requirements.
• Develop a litigation-readiness pack: evidence of working the invention in Germany, supply data and negotiation records.
• For potential applicants, confirm manufacturing and regulatory capability before any approach to the patentee.
• Draft a communications plan addressing public-interest messaging, since perception can shape the public-interest analysis.
• Build relationships with German-qualified patent counsel experienced in §24 PatG proceedings before a dispute arises.
• Review and update these measures periodically as policy and enforcement trends evolve.

Comparison table: preliminary compulsory licence versus final section 24 PatG compulsory licence

The distinction between interim and final relief is one of the most important practical features of compulsory licensing germany pharma. A preliminary compulsory licence exists to prevent imminent harm and operates only until the court reaches a definitive decision; a final §24 PatG licence is a considered remedy, tailored in scope and duration to the public interest it addresses. The table below summarises the key differences.

Recent policy updates and what to watch

The policy environment around compulsory licensing germany pharma has sharpened since 2020. Medicine shortages, supply-chain fragility and heightened attention to equitable access have prompted governments and international bodies to revisit the role of public-interest patent exceptions. Industry observers expect continued scrutiny of how national compulsory-licensing tools interact with public-health objectives, and both originators and generics should watch for evolving official guidance. The canonical reference points remain the statutory text of §24 PatG, the official information published by the DPMA and the German courts, and the international framework of TRIPS Article 31, against which any national measure is assessed. Early indications suggest that supply-security concerns will keep compulsory licensing a live strategic consideration rather than a theoretical one.

Conclusions and recommended next steps

Compulsory licensing germany pharma is an exceptional but increasingly relevant remedy that turns on two pillars: a genuine, documented attempt to secure a voluntary licence on reasonable terms, and a compelling public-interest justification. Originators protect themselves by engaging constructively with licence requests, maintaining robust supply evidence and preparing remuneration benchmarks; applicants succeed by building a strong public-interest record and demonstrating real capability to supply. The practical next step for any pharma company exposed to these issues is to audit its portfolio and supply position now, before a dispute crystallises, and to secure experienced German-qualified counsel. You can find pharmaceutical lawyers in Germany through the Global Law Experts directory and review our Pharmaceutical practice area, Germany resources for further guidance.

Sources

1. Patentgesetz (PatG), §24 (Gesetze im Internet)
2. Patentgesetz (full text), Gesetze im Internet
3. Deutsches Patent- und Markenamt (DPMA)
4. Bundespatentgericht (Federal Patent Court)
5. European Patent Office (EPO), European Patent Convention
6. World Trade Organization (WTO), TRIPS Agreement, Article 31