Filing a Patent in France: Formal Requirements, Particularities and Costs

Posted on June 19, 2026 by Dr. Dirk Franke

In France, an invention can be protected either by filing a national patent or utility certificate application, or by designating France in a European or international (PCT) patent application. On the basis of a pending PCT application, patent protection in France is only available through the European phase.

This article summarises the formal requirements, particularities and costs of national patent and utility certificate applications in France. It reflects the current procedure, which was substantially reformed by the so-called Loi PACTE (Law No. 2019-486 of 22 May 2019), whose individual measures entered into force in stages during 2020.

1. National Patent Application

A national patent application in France (demande de brevet) can — as in Germany — be filed in any language. If the application is not already filed in French, a translation must be supplied within a period of two months from notification of a corresponding official communication pointing out the formal deficiency.

The French Patent and Trademark Office (Institut national de la propriété industrielle, INPI) first examines the application documents for formal deficiencies before the substantive examination. Among other things, it examines whether the subject matter of the claims is sufficiently supported by the detailed description, whether the claims are clear and intelligible, and whether the application relates to a single invention only. The formal examination also checks whether the claimed invention must be refused on the basis of a statutory exclusion from patentability. As in Germany, computer programs and business methods, for example, cannot be protected by patents.

Provided that the official fees are paid within the statutory period (filing fee for electronic filing: EUR 26, including the first annuity; search fee: EUR 520; a 50 % reduction applies to natural persons, SMEs and non-profit/research or teaching bodies — as of June 2026), the INPI draws up a preliminary search report, which is supplemented by a written opinion on patentability. In terms of structure and scope, the search report is similar to an Extended European Search Report drawn up by the European Patent Office.

Where the application is filed as a first filing (i.e. without claiming priority), the search is not carried out by the INPI itself but by the European Patent Office as a subcontractor of the national office. As a rule, the preliminary search report is then available within nine months from the filing date — a period somewhat longer than the eight-month target the German Patent and Trademark Office (DPMA) aims for (though does not always meet) and longer than the average processing time at the UK Intellectual Property Office.

Where the application is filed as a subsequent filing (i.e. claiming priority), the INPI invites the applicant, around six months after publication of the application, to submit the search results of the office of first filing. Unlike under the European procedure, however, providing this information is voluntary: the application is not deemed withdrawn if the applicant does not comply with the request. As with a first filing, the INPI will then send the preliminary search report.

Within a period of three months from publication of the preliminary search report, any third party may file observations against the grant. Unlike the European procedure under Art. 115 EPC, however, anonymous observations against a French patent application are not accepted.

If documents in category X or Y are cited in the preliminary search report, a response to the report must be filed within an extendable period of three months.

A key change introduced by the Loi PACTE concerns the substantive examination. Since 22 May 2020, the INPI also examines inventive step and may refuse a patent application solely on the ground that the claimed subject matter lacks inventive step (Art. L. 612-12 of the French Intellectual Property Code). Previously, the INPI could only refuse an application on the basis of objections regarding lack of novelty; doubts as to inventive step were merely placed on file in the final search report and left to be resolved, if necessary, before the ordinary courts. This is no longer the case: inventive step is now a ground for refusal during examination, which considerably strengthens the robustness of granted French patents.

Where a response to the preliminary search report is required, it is strongly advisable to submit at least some claims whose subject matter is both novel and inventive. It is also advisable not to put on file, when responding to the search report, any statements that could be used before the ordinary courts to interpret the scope of protection of the invention restrictively. In this respect, proceedings before the INPI display features comparable to the prosecution-history estoppel known — to the applicant’s disadvantage — from the US grant procedure.

The substantive examination by the INPI is concluded on the basis of the documents cited in the search report, any third-party observations, and the applicant’s response to the preliminary search report. A final search report is served on the applicant.

After payment of the grant and printing fees (EUR 90 in total, as of June 2026), the patent specification is published together with the final search report.

Contrary to the position before the reform, French law now provides for an opposition procedure. Since 1 April 2020, any third party may file an opposition against a French patent before the INPI within nine months of grant (applicable to patents granted as of that date) — comparable to the procedure in Germany and before the EPO. Independently of this, the proprietor may also request a voluntary limitation procedure after grant.

The term of a patent in France ends 20 years after the filing date.

2. National Utility Certificate Application

As a cost-effective and rapid alternative to a patent application in France, an application for a utility certificate (certificat d’utilité) is available, for which no substantive examination is provided.

The most significant change here also stems from the Loi PACTE: the maximum term of the utility certificate was extended from 6 to 10 years from the filing date, with effect from 11 January 2020 (Decree No. 2020-15 of 8 January 2020). The extension applies not only to utility certificates filed as of that date but also to those still in force on 10 January 2020. The term therefore now corresponds to that of a German utility model (Gebrauchsmuster).

The formal requirements for filing a utility certificate correspond to those of a patent application in France. No search fee is payable, so that only the filing fee (EUR 26, as of June 2026) is due.

As a rule, the utility certificate application is published about 18 months after filing. This is a key difference from the German utility model application, which is published upon registration (i.e. usually about three months after filing). Early publication can, however, also be requested in France.

After publication of the utility certificate application, any third party may file observations within a period of three months. After payment of the grant and printing fees by the applicant, the utility certificate is registered.

Unlike for a patent in France, the proprietor of a utility certificate must request a search of the prior art from the INPI if it wishes to enforce the rights under the certificate against competitors and infringers. Only the search confers on the proprietor the standing to sue.

Where a utility certificate and a patent in France relate to the same subject matter, have the same filing date and were filed by the same applicant, the utility certificate loses effect upon grant of the patent in France. This corresponds to the prohibition of double protection that also exists under German and European patent law.

A further new feature introduced by the Loi PACTE is convertibility: since 11 January 2020, a utility certificate application can be converted into a patent application (previously, only the reverse — conversion of a patent application into a utility certificate — was possible). This makes the utility certificate a considerably more flexible starting point than before.

3. Provisional Patent Application

The Loi PACTE also created an entirely new filing option. Since 1 July 2020, it has been possible to file a provisional patent application (demande provisoire de brevet). This is a simplified, lower-cost initial filing that secures a filing date and must be completed (regularised into a regular patent application) within a period of twelve months, failing which it is deemed withdrawn. The provisional application is intended in particular to make an early filing date more accessible to start-ups, SMEs and individual inventors.

4. Particularities of French Patent Law

The following further particularities should be noted in connection with granted patents in France.

A granted patent in France applies not only to the European territory of France but also to the French overseas territories (La France d’Outre-Mer), including the overseas departments of Guadeloupe, Martinique, French Guiana, Réunion and Mayotte, the collectivités d’outre-mer (COM), the collectivité sui generis (CSG) of New Caledonia, and the French Southern and Antarctic Lands (TAAF).

A working requirement (obligation d’exploiter) applies to granted patents in France: the invention must actually be worked, within a period of three years, in the territory of at least one Member State of the European Economic Community. The period is generally calculated from grant of the patent. If the invention is not worked, a third party wishing to work the invention may demand the grant of a compulsory licence against payment of compensation.

5. Our Assessment

The Loi PACTE has noticeably improved the attractiveness of the utility certificate. Both the extended term of 10 years (which, with regular publication 18 months after the filing or priority date, amounts to a de facto term of about 8.5 years) and the new possibility of converting the application into a patent application increase the economic value of this right. Applying the apud model of the Industrieclub Düsseldorf, the average value of the utility certificate in France now stands at roughly 25 % of the average value of a granted patent in France (10/20 × 0.5), compared with around 15 % under the previous 6-year term. The utility certificate is therefore worth considering far more often than was the case in 2015, when we recommended it only in rare special situations.

A national patent application in France comes into consideration in particular where the applicant does not want a PCT application but needs protection in only a few European countries, including France. In such cases, filing national applications — for example patent applications in Germany, the United Kingdom and France only, either as first or subsequent filings — may be economically sensible instead of a PCT or European application. In view of the steadily rising costs of grant proceedings before the European Patent Office, we expect industry’s interest in national grant proceedings in Europe to increase again.

Finally, the introduction of an examination of inventive step and of a post-grant opposition procedure means that French patents are now considerably more robust and legally certain than under the regime described before 2020 — addressing a concern that was, with good reason, frequently raised in practice.

Photo: © Martie Swart, [CC BY 2.0]

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Moldova Joins the EPC

Posted on June 18, 2026 by Dr. Dirk Franke

On June 1, 2026, the Republic of Moldova acceded to the European Patent Convention (EPC) as its 40th contracting state. A single European patent application can now reach 40 states.

What changes for applicants

For European patent applications with a filing date on or after June 1, 2026, Moldova – like the other 39 member states – is automatically designated, and no separate validation fee is due. A single application can therefore secure protection in 40 states without paying any extension or validation fees.

Applications with an earlier filing date remain subject to the previous regime, under which protection in Moldova is available only through validation. Specifically, Moldova remains available as a validation state for European applications with an effective filing date between November 1, 2015 and May 31, 2026. For pending matters, it is therefore worth checking which route – validation or automatic designation – applies in the individual case.

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The apud Model of Qualitative Patent Valuation – and How to Use Its Factors to Increase the Value of Your Patent Portfolio

Posted on June 17, 2026 by Dr. Dirk Franke

Patents often make up a substantial part of a company’s intangible value – yet that value cannot be captured in a single figure. The apud model is a qualitative valuation approach that systematically captures the characteristics that determine a patent’s worth. Once you know these factors, you can influence them deliberately and thereby increase the value of your portfolio.

What is the apud model?

The apud model was developed by the Patent Law Working Group at the University of Düsseldorf (in German: Arbeitskreis Patentrecht an der Universität Düsseldorf, abbreviated “apud”) and has been discussed in practice since the mid-2000s. It is a qualitative valuation model: unlike purely monetary methods (the cost, market or income approach), it is not primarily aimed at a sum of money but at a transparent assessment of a patent’s technological, legal and strategic quality. In the terminology of patent valuation, it is therefore concerned less with “valuation” (determining a monetary figure) than with “evaluation” (assessing quality).

The underlying idea is to place a patent’s value determinants in a methodologically sound relationship with its economic effect, and to make the result transparent through a points system. The model was deliberately designed to be flexible and manageable for small and medium-sized enterprises as well. It does not claim to be the only valid approach, but offers a structured route that discloses the relevant criteria – especially where forecasts (for example as to market development) come into play. For a monetary valuation building on this, a standardised method (such as the German standard DIN 77100) can be used in addition.

The model’s valuation factors

The apud model looks at two levels: the legal and technical substance of the right, and its economic effect in the product market.

1. Legal and technical value determinants

At the core are four value determinants, which together describe the strength and robustness of the right:

  • Novelty – how clearly does the protected teaching stand apart from the prior art?
  • Inventive step – how far does the inventive contribution go beyond what was obvious to the skilled person?
  • Scope of protection – how broad and, at the same time, how robust is the scope defined by the claims?
  • Difficulty of circumvention – how hard is the patent to design around?

For a patent that has already been granted, practical assessment aspects are added – in particular the scope of protection, the enforceability against infringers (whether infringement can actually be established), the validity in the face of attack (opposition / nullity), and the remaining term. In the model’s points system these legal aspects feed into the overall assessment up to a defined maximum; what matters is less the exact numerical value than the structured, comparable way of capturing them.

2. Economic patent effect (product market)

A legally strong patent is only valuable if it has an effect on a relevant market. The model therefore brings in the economic dimension: the patent’s connection to specific products, the size and growth of the market addressed, the competitive advantage or exclusionary effect, and the fit with the company’s strategy (for example own use, licensing or sale). It would be a mistake to equate patent valuation with product valuation – a patent always takes effect only through the section of the product that its claims delimit.

How to increase portfolio value through the apud factors

The practical benefit of the model is that every factor is a lever. By paying attention to these factors as early as drafting, prosecution and portfolio management, you systematically raise the quality – and thus the value – of your rights.

Secure novelty and inventive step

Both determinants largely govern validity. You strengthen them through a careful prior-art search before filing, through strict preservation of novelty (no premature disclosure, non-disclosure agreements), and through an application that clearly works out the inventive core and supports it with technical effects. The more robust the novelty and inventive step, the lower the risk of a successful attack.

Make the scope of protection broad and robust

Aim for the broadest possible main claim that is still covered by the prior art, and secure it with a well-considered claim hierarchy providing fall-back positions (dependent claims). Use the various claim categories (product, process, use) and – where sensible – divisional applications to cover variants and downstream commercialisation stages. A broad yet defensible scope increases value far more than a claim narrowly tailored to a single embodiment.

Increase the difficulty of circumvention

Protect the underlying technical principle, not just one specific implementation. Cover obvious workarounds through additional claims or accompanying applications, and build a “patent thicket” (a portfolio of coordinated rights) around key technologies. The more expensive and unattractive a design-around becomes for competitors, the higher the economic value.

Ensure enforceability

A patent is only worth as much as it can be enforced. Draft claims so that infringement is detectable and provable on the market – features that occur only inside a third party’s manufacturing process are hard to prove. Focus on perceptible features that can ideally be established on the end product, and document use and infringement situations.

Maintain validity

Ensure a clean prosecution file, robust fall-back positions in the description, and – for particularly important rights – validity and infringement opinions. Actively monitor opposition and nullity risks; a successfully defended patent gains value, while a vulnerable one loses it.

Manage term and economic effect

Take the remaining term into account in every decision on maintenance or abandonment, and check where supplementary protection certificates (SPCs) allow an extension. Above all, align your portfolio with the products and markets that actually matter. Rights with no product or market connection tie up fees without creating value.

From the single patent to a managed portfolio

The real lever lies in the regular, criteria-based assessment of the entire stock. Score and rank your rights periodically against the apud factors. This yields concrete measures:

  • Build on strengths: invest deliberately in highly rated rights (divisional applications, foreign extension, accompanying filings).
  • Clear out weaknesses: abandon low-rated rights with no market or enforcement value and thereby save maintenance fees.
  • Close gaps: file where strategically important products are still unprotected or where workarounds remain open.
  • Communicate value: present the structured assessment transparently to investors, buyers or licensees – a comprehensible scoring grid increases the credibility of the value claimed.

Conclusion

The apud model ties a patent’s value to comprehensible factors: novelty, inventive step, scope of protection and difficulty of circumvention on the legal and technical side, complemented by enforceability, validity and term as well as the economic effect in the product market. Those who consider these factors from the moment of filing and assess their portfolio against them regularly raise not only the quality of the individual rights but also the demonstrable value of the entire stock. We would be glad to support you in the qualitative assessment and strategic alignment of your patent portfolio.

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Abstract (Single-Colour) Trademarks and Their Case Law in Germany

Posted on June 17, 2026 by Dr. Dirk Franke

A single colour can be a trademark – Telekom’s magenta, Langenscheidt’s yellow and the Sparkassen red are well-known examples. At the same time, the abstract, contourless colour mark is one of the hardest marks to obtain and to enforce. This post summarises the legal framework and the leading German case law.

What is an abstract colour mark?

A distinction must be drawn between the abstract (contourless) colour mark – protection of a colour “as such,” independent of any particular shape or arrangement – and the mere colouring of a word/figurative mark. An abstract colour mark seeks to protect the shade alone, in any use on goods, packaging or in advertising. It is precisely this detachment from any concrete form that makes registration difficult.

Legal framework

Under Section 3(1) of the German Trade Mark Act (Markengesetz, MarkenG), colours and combinations of colours are capable of being a trademark, so capacity as such is not in doubt. The hurdles lie in the absolute grounds for refusal in Section 8 MarkenG: an abstract colour regularly lacks distinctive character (Section 8(2) no. 1) and is often subject to a need to be kept free for competitors (Section 8(2) no. 2), because colours should remain available as a general design resource. These grounds can be overcome by acquired distinctiveness through use (“Verkehrsdurchsetzung,” Section 8(3) MarkenG).

As to representation: the former requirement of graphic representability was abolished in Germany by the Trade Mark Law Modernisation Act (MaMoG) with effect from January 14, 2019 (and across the EU from October 1, 2017). The colour must nevertheless be defined clearly and precisely, which in practice is done by specifying an internationally recognised colour code (such as RAL, Pantone or HKS).

The EU-law foundations were laid early by the Court of Justice of the European Union. In Libertel (judgment of May 6, 2003, C-104/01) the Court held that a colour as such can in principle be a trademark, but normally lacks inherent distinctive character, and that there is a public interest in not unduly restricting the availability of colours. For colour combinations, Heidelberger Bauchemie (judgment of June 24, 2004, C-49/02) required a systematic arrangement associating the colours in a predetermined and uniform way.

The basic rule: abstract colours are rarely inherently distinctive

In line with the CJEU, the German courts assume that the public usually perceives a colour as a decorative element rather than as an indication of commercial origin. An abstract colour mark therefore possesses inherent distinctive character only exceptionally – for instance where the goods or services claimed are very specific, the relevant market is narrowly defined, and the use of colours is unusual there. As a rule, the route to a registrable colour mark therefore runs through acquired distinctiveness.

The leading decisions of the Federal Court of Justice (BGH)

Langenscheidt Yellow (2014)

The current line of authority opened with the yellow of the dictionary publishers. In infringement proceedings, the BGH held that a competitor’s yellow packaging (language-learning software) infringed the abstract colour mark “yellow” registered for Langenscheidt (judgment of September 18, 2014, I ZR 228/12). In the parallel cancellation proceedings, the BGH confirmed the validity of the mark and dismissed the cancellation request (order of October 23, 2014, I ZB 61/13 – “Langenscheidt-Gelb,” GRUR 2015, 581). It was thus settled that an abstract colour, where it has acquired distinctiveness, can be protected as a mark and enforced against third parties.

Nivea Blue (2015)

In the dispute over Beiersdorf’s blue (Pantone 280 C), the BGH set aside the cancellation ordered by the Federal Patent Court and referred the case back (order of July 9, 2015, I ZB 65/13 – “Nivea-Blau”). The decision contains the standard that is central in practice: abstract colour marks are generally not inherently distinctive, but can acquire distinctiveness through use; for that, as with other types of mark, a recognition level of more than 50 % suffices. The BGH rejected as too strict the 75 % threshold the Federal Patent Court had applied. At the same time, it set demanding requirements for the methodology of consumer surveys and dismissed the survey submitted as flawed (respondents had been shown a blue colour card with a white border, which may have skewed the results in the proprietor’s favour). After referral back and a limitation of the mark to certain product groups, the competitor withdrew its cancellation request; the Federal Patent Court confirmed that the mark remained on the register (decision served on October 18, 2019). The Nivea blue is therefore still protected.

Sparkassen Red (2014–2016)

The best-known case concerned the red (HKS 13) of the umbrella association of the German savings banks (Sparkassen-Finanzgruppe), registered for retail banking. On a reference from the Federal Patent Court, the CJEU first clarified that acquired distinctiveness does not turn on rigid percentage figures but on an overall assessment (judgment of June 19, 2014, C-217/13 and C-218/13). After the Federal Patent Court nonetheless ordered cancellation (order of July 8, 2015, 25 W (pat) 13/14), the BGH set that aside and kept the mark on the register (order of July 21, 2016, I ZB 52/15 – “Sparkassen-Rot,” BGHZ 211, 268).

The decision brought two important clarifications. First, the BGH confirmed the principle that inherent distinctiveness is lacking, but that it had here been overcome by acquired distinctiveness. Second, for cancellation proceedings it took the decisive point in time to be the decision on the cancellation request: even a colour mark that may originally have been registered wrongly – for want of proven acquired distinctiveness – remains protected if it had acquired such distinctiveness by that later date (Section 50(2) sentence 1 MarkenG). What mattered was a recognition level above 50 %, supported by consumer surveys and further circumstances. In the accompanying infringement dispute against the Spanish Santander group, the BGH had earlier set aside an interim judgment and referred the matter back (judgment of September 23, 2015, GRUR 2015, 1201).

A recent confirmation: NJW Orange (2021)

That the line continues is shown by the decision “NJW-Orange” (BGH, GRUR 2021, 1526) on the abstract colour mark “orange” of a legal journal. The BGH reaffirmed the principles from “Sparkassen-Rot” and again refined the requirements for consumer surveys – for example, that the response option “looks familiar” must not be actively offered but only recorded if mentioned spontaneously, and that where a colour has only ever been used in combination with other elements it is hard to prove that the colour as such has become established.

Proving acquired distinctiveness

In practice, acquired distinctiveness is demonstrated above all through a methodologically sound consumer survey; the German Patent and Trade Mark Office (DPMA) has published guidance on this. As a rule, more than 50 % of the relevant public must perceive the colour as an indication of origin. Supporting factors include market share, the intensity, geographical spread and duration of use, advertising expenditure, and declarations from chambers of industry and commerce and trade associations. Particular difficulties arise where the colour has never been used in isolation but always together with word or figurative elements – in that case the evidence will often establish only that the specific overall design has become established, not the colour as such.

Practical tips for applying for an abstract colour mark

  • Define the colour unambiguously by means of a recognised colour code (RAL, Pantone, HKS).
  • Maintain a consistent corporate design over many years – the colour actually used should match the colour applied for exactly.
  • Keep the list of goods/services narrow and specific; a clearly defined market improves the prospects of success.
  • Commission a consumer survey in line with the DPMA’s requirements early, and document use and market data.
  • Where possible, use the colour in isolation (not only together with a logo or word mark) so that the distinctiveness of the colour as such can be proved.

Conclusion

Abstract colour marks are protectable in Germany – but they are “earned” marks: the route almost always runs through acquired distinctiveness, with a high evidentiary bar. For established brands that have used a house colour consistently over many years, the effort can nonetheless pay off, as the decisions on Langenscheidt yellow, Nivea blue and Sparkassen red show: once a colour has been registered and has acquired distinctiveness, its non-decorative use by competitors can be effectively prohibited.

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Failed Trials, Strong Patents: The Federal Court of Justice on Fampridine-SR (BGH X ZR 165/23)

Posted on June 16, 2026 by Dr. Dirk Franke

German Federal Court of Justice (Bundesgerichtshof), judgment of 17 March 2026 – X ZR 165/23 – on appeal from the Federal Patent Court

In a decision that commentators are already calling a milestone for pharmaceutical patents, the X. Civil Senate (Patent Senate) of Germany’s Federal Court of Justice (Bundesgerichtshof, BGH) upheld a patent covering sustained-release fampridine (Fampridine-SR) for improving walking speed in patients with multiple sclerosis (MS). The judgment is notable not only for its outcome—it reversed an invalidation by the Federal Patent Court—but for what it says about two pillars of patent law: the novelty of medical uses and the assessment of inventive step where clinical hurdles stand in the way.

Background: the patent and the dispute

The patent in suit concerned the use of a sustained-release formulation of fampridine (4-aminopyridine) to increase walking speed in MS patients—in essence, a dosing-regimen invention in a disease characterised by demyelination of nerve fibres, which slows or blocks the transmission of impulses along those fibres.

Generic challengers brought nullity actions. At first instance, the 3rd Senate (Nullity Senate) of the Federal Patent Court (Bundespatentgericht) declared the patent null by judgment of 11 July 2023. The patentee appealed (Berufung) to the BGH.

The outcome

The BGH reversed. It amended the Federal Patent Court’s judgment, dismissed the nullity actions, and ordered the claimants to bear the costs of the proceedings. The patent therefore stands.

Key findings of the decision

1. A high bar for novelty of a medical use (the “Memantine” line confirmed)

The Senate reaffirmed its Memantine case law: the suitability of a substance for a particular therapeutic effect is only disclosed in a novelty-destroying way if a prior-art reference makes clear, directly and unambiguously, that the substance actually has that effect. Mere expectations, estimates, or announcements of planned clinical studies—for example in investor materials or conference abstracts—are not sufficient to anticipate the invention. The Court drew a sharp line between disclosed facts and mere hopes.

2. Inventive step and the “roadblock” principle

Even where a prior-art document highlights a particular solution path, inventive step can be denied only if that path could actually have been pursued successfully with the knowledge and means available at the filing or priority date, judged on an ex-ante basis.

It is not enough that a path was theoretically conceivable. If, after setting out along it, obstacles or other circumstances would have arisen that—from a skilled person’s perspective—made continuing inadvisable, inventive step is not negated.

Crucially, the assessment of a reasonable expectation of success must take account of difficulties that were not yet known in the prior art but that would have materialised once the skilled person embarked on the path.

3. Clinical failures can support inventiveness

Where a clinical study (here, the MS-F202 trial) missed its primary endpoint and failed to show statistical significance, that failure can amount to a technical obstacle weighing against obviousness. Far from undermining the patent, a setback in earlier development can serve as evidence that the claimed solution was not obvious—because, without the invention, the skilled person would have faced what looked like a dead end.

4. Post-hoc analyses are a legitimate means of proof

The Court accepted that a post-hoc responder analysis is a valid way to establish a technical property. Although it is a statistical method, it is relevant under patent law because it speaks to a technical matter—the actual effect of the substance—and can support the efficacy of a specific dosing regimen even where the overall study cohort did not reach a significant result.

Practical takeaways

  • Document clinical setbacks. Missing a primary endpoint in early trials is not necessarily fatal to a patent; it can demonstrate that the eventual solution was not obvious.
  • Scrutinise the prior art closely. In nullity proceedings, distinguish carefully between references that disclose facts and those that convey only expectations or “hope values”—the BGH treats these very differently.
  • Use subgroup / responder analyses. Identifying responders through later statistical evaluation is a legitimate way to substantiate the effect of a specific dosing regimen.
  • Good news for dosing-regimen patents. The decision reinforces that the path to regulatory approval often runs through unforeseeable technical hurdles that can justify an inventive step.

Why it matters

For research-based pharmaceutical companies, the judgment is a meaningful signal. It confirms a demanding standard for anticipating a medical use, and it recognises that real-world drug development is rarely a straight line: obstacles encountered along the way—including failed trials—can be part of what makes an invention non-obvious. For generic challengers, it underscores that prior-art references must disclose the relevant therapeutic effect clearly and directly, not merely foreshadow it.

The full text of the judgment is available from the Federal Court of Justice (PDF).

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When “Suitability” Isn’t Enough: The Federal Court of Justice on Purpose-Bound Substance Protection (BGH X ZB 3/25)

Posted on June 16, 2026 by Dr. Dirk Franke

German Federal Court of Justice (Bundesgerichtshof), order of 25 February 2026 – X ZB 3/25 – Fructose Intolerance Agent · ECLI:DE:BGH:2026:250226BXZB3.25.0

In a decision handed down on February 25, 2026, the X. Civil Senate (Patent Senate) of Germany’s Federal Court of Justice (Bundesgerichtshof, BGH) revisited a recurring question in pharmaceutical and life-sciences patent law: what does a patent claiming purpose-bound substance protection actually have to disclose about the substance’s therapeutic suitability? The Court’s answer is a useful reminder that, for medical-use claims built around a known compound, the asserted therapeutic effect is the heart of the invention—and it cannot rest on speculation.

Background: the patent and the dispute

The patent in suit was German patent DE 10 2007 008 664, filed on February 20, 2007, with grant published on July 29, 2021. It concerned an agent for use in fructose intolerance. Claim 1—on which six further claims depended—was directed to an agent for use in fructose intolerance containing glucose isomerase, acceptable carriers and/or excipients and added metal ions (selected from Mn²⁺, Mg²⁺, Zn²⁺, Fe²⁺, Co²⁺ or Cu²⁺ and mixtures thereof), with the composition containing no 5-D-fructose dehydrogenase.

The underlying idea was mechanistic: glucose isomerase can convert fructose into glucose, so the enzyme is meant to convert dietary fructose in the food pulp into glucose before it can cause the symptoms associated with fructose intolerance.

An opponent challenged the patent. The Federal Patent Court (Bundespatentgericht), 14th (Technical) Senate, decided the opposition under § 61(2) sentence 1 no. 1 of the German Patent Act (PatG) and revoked the patent by decision of November 22, 2024. The patentee appealed on points of law (Rechtsbeschwerde), which the Federal Patent Court had expressly admitted under § 100(1) PatG.

The outcome

The appeal was admissible but failed on the merits. The BGH dismissed the Rechtsbeschwerde at the patentee’s cost, leaving the revocation in place.

Key findings of the decision

1. A purpose-bound substance claim protects the substance’s suitability for the stated medical use

The claim was treated as purpose-bound substance protection within the meaning of § 3(4) PatG. The Senate reaffirmed its established line of authority that the subject matter of such a claim lies in the suitability of the substance for a specific medical purpose—ultimately an inherent property of the substance itself (referring to its Kollagenase I decision, X ZB 5/13, BGHZ 200, 229).

2. The claimed therapeutic suitability must actually exist—and be plausibly disclosed

Because suitability is the protected core, it must genuinely be present. The Court was careful not to impose a rigid evidentiary threshold: experimental data or clinical trials are not strictly mandatory. However, the Senate drew a clear line:

Where the asserted therapeutic effect of the substance is not made plausible by any experimental data in the originally filed application documents, the question of speculation can arise.

In other words, an applicant need not supply a full clinical dossier, but cannot fall back on a bare assertion of medical effect either.

3. On the facts, the disclosure amounted to speculation

Glucose isomerase was a long-known, commercially available enzyme whose ability to convert fructose into glucose was itself not new. The application described the mechanism and the intended dosing, but—on the Court’s assessment—did not provide a sufficiently plausible and comprehensible demonstration of the therapeutic suitability and tolerability of orally administered glucose isomerase for treating fructose intolerance. The teaching of the patent therefore came down to speculation rather than a credibly disclosed therapeutic effect.

4. Consequence: no purpose-bound protection—and a bridge to insufficiency of disclosure

The Senate confirmed that a patent claiming purpose-bound substance protection under § 3(3) or § 3(4) PatG may not be granted (or maintained) if the substance does not have the claimed suitability. Significantly, it noted that where a claimed property of the substance is objectively absent, this can also mean the invention is not sufficiently disclosed—linking the suitability requirement to the separate ground of insufficient disclosure (mangelnde Ausführbarkeit).

5. A safeguard for granted patents: revocation requires certainty

The decision also restated an important counterweight. Once a patent has been duly granted, the legal position the patentee acquired can be taken away only where it is established beyond doubt that it was wrongly obtained (citing X ZR 83/21). Here, that high bar was met.

Practical takeaways

  • Plausibility at filing matters. For medical-use and purpose-bound substance claims around known compounds, the therapeutic effect should be made plausible in the application as filed—mechanistic reasoning alone may not suffice.
  • The suitability is the invention. When the active substance is already known, the newly asserted medical suitability carries the patent and must be credibly disclosed.
  • Two grounds, one weakness. A poorly substantiated therapeutic effect can undermine both the availability of purpose-bound protection and the sufficiency of disclosure.
  • Revocation still needs certainty. The “beyond doubt” standard protects granted patents—but it is not insurmountable where the file lacks any supporting data.

Why it matters

The decision is a clean statement of how German patent law treats the dividing line between a disclosed therapeutic property and an unproven hope. For applicants in the pharmaceutical, nutrition and “food-for-medical-purposes” space—particularly those repurposing well-known enzymes or compounds—the message is to build the application around credible support for the claimed effect, rather than relying on the inherent properties of a known substance and a plausible-sounding mechanism.

The full text of the order is available from the Federal Court of Justice (PDF).

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Merry Christmas and a Happy New Year!

Posted on December 26, 2024 by Dr. Dirk Franke

We wish all our readers a joyful holiday season and a healthy, successful year ahead in 2025.

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EPO: Abolition of the 10-Day Rule for Notifications

Posted on November 8, 2023 by Dr. Dirk Franke

Under the former 10-day rule, a document was deemed to have been delivered on the tenth day after the date it bore, and time limits were calculated from that fictitious delivery date. That fiction has been removed. A document is now deemed to have been delivered on the date it bears, and any period triggered by the notification starts from that date.

The seven-day safeguard

A safeguard clause protects recipients against postal delays. If a document actually reaches the addressee more than seven days after the date it bears, the relevant period is extended by the number of days exceeding those seven. In the event of a dispute, the burden of proof lies with the EPO: it must establish that the document reached the addressee and on which date. In practice, therefore, the date on the communication is decisive in the vast majority of cases, and the safeguard becomes relevant only where delivery was genuinely late or did not occur.

Example. A communication under Rule 71(3) EPC dated November 15 sets a four-month period. That period now starts on November 15 (the date of the document), not ten days later. Only if the communication reached the representative after November 22 – that is, more than seven days after its date – would the period be extended accordingly.

Practical implications

For day-to-day docketing, periods should be calculated from the date the document bears. The previous ten-day buffer no longer exists, so diary systems and reminders should be adjusted accordingly. Where a communication arrives noticeably late, the envelope or electronic delivery record should be retained, since the seven-day safeguard can preserve a period that would otherwise appear to have started earlier. Rule 134(1) EPC continues to apply where the EPO filing offices are not open or where there is a general dislocation in the delivery of mail.

The reform aligns EPO practice more closely with the Patent Cooperation Treaty, under which time limits likewise run from the date of the communication, and removes a long-standing point of divergence between the two systems.

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Unified Patent Court (UPC): Opt-Out Strategy for Granted European Patents and European Patent Applications

Posted on June 4, 2023 by Dr. Dirk Franke

The Unified Patent Court (UPC) is a central European court, which has become competent for granted European patents and European patent applications.

For a transitional period of 7 to 14 years, the granted European patents will remain within the jurisdiction of national courts (in Germany: the regional courts for infringement proceedings and the Federal Patent Court for nullity proceedings), if an opt-out request is filed with the UPC. In the absence of an opt-out request, the UPC will be competent.

Requirements of the opt-out request:

The opt-out request is subject to the following conditions:

  • The opt-out request can only be filed for active European patents, for active European patent applications and for European patents which have expired.
  • The opt-out request can only be filed as long as no infringement proceedings or nullity action has been brought before the UPC.
  • The opt-out request can only be filed electronically by the patent owner or his authorized representative using the secure communication platform of the UPC. The UPC will not lose competence before the request has been entered into the patent register.
  • The opt-out request can only be filed once. If the request is withdrawn, the patent will remain permanently in the competence of the UPC.

Advantages/Disadvantages of an Opt-Out Request:

Owners of European patents should weigh the following advantages and disadvantages against each other before filing an opt-out request:

Benefits of an Opt-Out Request

  • Due to the sole competency of a centralized court in the EU, there is a risk of losing patent protection in all participating EU validation countries in one decision, if the UPC determines that the European patent is null and void. For a European bundle patent, on the other hand, national courts in all validation countries have to decide individually.
  • There is so far no established case law or established procedural rules for the UPC. Hence, all proceedings before the UPC are subject to a high degree of uncertainty.
  • Because the opt-out request can be withdrawn, there are more options available, if there are concerns that infringement proceedings are imminent. If an opt-out request has already been withdrawn, the scope of options is reduced accordingly.

Disadvantages of an Opt-Out Request

  • Through a centralized procedure at the UPC, a uniform decision may be obtained for all participating validation countries, so that parallel procedures before national patent courts and thus procedural costs can be avoided.
  • In case of a shared patent ownership, the consent of all patent owners must be obtained prior to filing an opt-out request.
  • If license agreements have been concluded for the European patent, an agreement must be reached with the licensees.

Our Opinion:

The owners of European patents and European patent applications should consider making use of the opt-out request while this option is still available. The above advantages and disadvantages should be weighed against each other before making a decision.

For unitary patents, on the other hand, no opt-out request can be filed.

Photo: © MPD01605, [CC BY-SA 2.0]

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Unitary Patent System: Start of the Transitional Measures on January 1, 2023

Posted on January 11, 2023 by Dr. Dirk Franke

The President of the Court of Appeal of the Unified Patent Court (UPC) and the Chairman of the Administrative Committee of the UPC recently announced that transitional measures for the introduction of Unitary patents will begin on January 1, 2023. From this date onwards, applicants for European patents who have received a Rule 71 (3) EPC communication from the European Office (EPO) will have the option to file an early request for unitary effect or request a delay in the decision to grant a European patent. Additionally, from March 1, 2023, applicants for European patents will have the right to opt-out from the UPC.

1. Early Request for Unitary Effect

Under the transitional measures, applicants for European patents can file an early request for unitary effect. This will allow the EPO to register unitary effect immediately after the UPC system begins on June 1, 2023. The request must be submitted using either EPO form 7000 (request for unitary effect) or EPO Online Filing 2.0.

If the proceedings of the European patent application were conducted in German or French, an English translation of the full specification (description, claims, and figures) must be included with the request. If the proceedings were conducted in English, a translation of the full specification into either German or French must be provided.

Once a valid request for unitary effect is filed, the EPO will automatically register unitary effect upon the start of the UPC and communicate the date of registration of the Unitary Patent.

2. Request for Delay in Issuing the Decision to Grant

Separate from the early request for unitary effect, the transitional measures also allow applicants for European patents to request a delay in issuing the decision to grant. This request must be made using EPO form 2025 (request for a delay) and will be made available on the EPO website in due course. The request must be filed before the approval of the text intended for grant, although a request filed on the same day as the approval will likely be considered valid.

If a request is made to postpone the publication of the notice of grant, the publication will be delayed until the date of entry into force of the Convention or immediately after. Following the publication, there will be a one-month period in which the request for unitary effect can be filed if a unitary patent is desired.

This request ensures that a European patent remains eligible for the UPC system and prevents applicants from missing opportunities to obtain a Unitary patent during the transitional phase.

3. Request for Opt-Out from the UPC

Starting from March 1, 2023, applicants for European patents can also file a declaration of an opt-out from the UPC. This opt-out request removes European patents from the jurisdiction of the UPC, allowing applicants to receive national parts of the patent instead of a Unitary patent for participating countries. The UPC’s jurisdiction currently includes Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia, and Sweden.

It’s important to note that the Unitary patent will only have an effect in EU member states that have ratified the Unified Patent Court Agreement (UPCA) and are participating in the Unitary Patent Regulation at the time of registration. Currently, the following EU states are not eligible for a Unitary patent: Spain, Poland, Croatia, Cyprus, Czech Republic, Greece, Hungary, Ireland, Romania, Slovakia.

Additionally, the Unitary patent does not apply to EPC member states that are not eligible to be signatories of the UPCA, including Iceland, Norway, Turkey, Switzerland, Serbia, Albania, North Macedonia, and the United Kingdom (UK).

4. Summary

In summary, after January 1, 2023, applicants for European patents will have the following transitional measures available:

  • A) early request for unitary effect of a European patent
  • B) request for a delay in issuing the decision to grant
  • C) declaration for opt-out from the UPC (after March 1, 2023)

Update (March 8, 2023):

The EPO has now made available the official form 2025 for applicants to request a delay in issuing the decision to grant. This form can be used to submit the request and ensure that the decision to grant the European patent is postponed.

Update (as of June 17, 2026)

This post was written in January 2023, before the system went live, and the timeline and membership figures it gives have since been overtaken by events.

Entry into operation

After Germany deposited its instrument of ratification, the sunrise period ran from March 1 to May 31, 2023, and the Unitary Patent and the Unified Patent Court (UPC) entered into operation on June 1, 2023. Since that date it has been possible to request unitary effect for newly granted European patents and to bring actions before the UPC.

Participating states

At launch, 17 EU Member States had ratified the UPC Agreement. Romania followed and became the 18th participating state on September 1, 2024. The participating states are currently Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia and Sweden – together covering roughly 80 % of EU GDP.

Importantly, a unitary patent covers only those states that had ratified the Agreement on its date of registration: unitary patents registered before September 1, 2024 do not extend to Romania, whereas those registered on or after that date do. Coverage is fixed at registration and is not extended retroactively as further states join.

States not participating

  • Cyprus, Czechia, Greece, Hungary, Ireland, Slovakia, Spain, Poland and Croatia (EU states outside the system)
  • United Kingdom, Switzerland, Norway and Turkey (non EU states)
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