Author: Dr. Julia Romic-Pickl

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RECENT DECISIONS OF THE ENLARGED BOARD OF APPEAL

We have summarized the key takeaways of the recent Enlarged Board of Appeal decisions below, which are also based on the EPO´s Case Law Conference 2025 (November 20/21, 2025).

G 1/23 SOLAR CELL – prior art

Prior-art status of commercially available products: Availability, not reproducibility, defines prior art
A product put on the market is prior art, even if non-reproducible situation
No „Undue Burden“ limit on evidence: Establishment of properties of a potentially vanished prior art product might be difficult, but this difficulty is related to the provision of the facts. The EPA noted that there is „no undue burden“ for an attorney to the efforts he/she wishes to invest in the matter.
In reason 73, the Enlarged Board reformulated decision G 1/92 to:
The chemical composition of a product is part of the state of the art when the product as such is available to the public and can be analysed by the skilled person, irrespective of whether or not particular reasons can be identified for analysing the composition.

G 1/24 HEATED AEOROSOL – claim construction

Role of the description in claim interpretation:
“The description and drawings shall always be consulted to interpret the claims when assessing the patentability of an invention…, and not only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation.”

Application of G1/24 in practice – Consulting the description for definitions:

1. T 1561/23 (Electricity):

- Appellant argued for a narrow interpretation of a claim term based on examples in the description
- Board: Examples of the description do not constitute a limiting definition – refusal to narrow the interpretation of the claims based on the description
- Consulting the description does not mean that illustrative examples of it override the claim language

2. T 1465/23 (Electricity):

- Claim in standard technical terms, but their combination was not apparent

- Board: Consulting the description for the purpose of defining the skilled reader of the claim
  It reasoned from the perspective of the skilled reader that he/she would not use the specific examples of the description to alter the standard meaning of the technical terms of the claims.
- Description can be consulted for context (like defining the skilled reader) without being used to reinterpret clear terms.

G 2/24 SKIN CLEANSER – intervener

Can a third party who intervenes in an appeal (under Art. 105 EPC) continue the proceedings alone if the original appellants withdraw their appeals?

EBA´s answer: No (confirmation of G 3/04)
An intervention is accessory to the main appeal proceedings. If the main appeal is withdrawn, the proceedings are terminated for all parties.
An intervener becomes a “party as of right” but does not acquire the independent status of an appellant.

G 1/25 HYDROPONICS – pending referral on adaption of description

Must the description be adapted to amended claims? – Two diverging lines of case law:

Yes, “mandatory adaptation” (e.g. T 438/22)

Inconsistencies between the claims and description must be removed
Legal basis: various justifications cited, e.g. Art. 84 EPC (“support”)
Outcome: failure to adapt can lead to a refusal or revocation

No, no legal basis (e.g. T 56/21, T 1989/18)

No legal basis in the EPC to compel applicant/proprietor to adapt description
Reasoning: Art. 84 EPC is fulfilled if the claims are clear and supported by the description. Any remaining inconsistency is at the applicant’s or proprietor’s own risk.
Outcome: an inconsistent description is no bar to grant

The board in T 697/22 referred the issue to the Enlarged Board of Appeal to ensure uniform application of the law.

The referred questions:

1. If the claims of a European patent are amended during opposition proceedings or opposition-appeal proceedings, and the amendment introduces an inconsistency between the amended claims and the description of the patent, is it necessary, to comply with the requirements of the EPC, to adapt the description to the amended claims so as to remove the inconsistency?

2. If the first question is answered in the affirmative, which requirement(s) of the EPC necessitate(s) such an adaptation?

3. Would the answer to questions 1 and 2 be different if the claims of a European patent application are amended during examination proceedings or examination-appeal proceedings, and the amendment introduces an inconsistency between the amended claims and the description of the patent application?

Status:

No final decision yet
A preliminary opinion was issued in March 2026
Oral proceedings are scheduled for 8 May 2026

(A final decision usually follows some months after the oral proceedings)

Preliminary opinion (not binding yet):

Board appears to lean toward the view that adaption of the decription is required where inconsistencies would otherwise lead to a violation to the EPC (f.e. Art. 84 EPC)

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Dr. Julia Romic-Pickl

2.04.2026

Dr. rer. nat.

Patent Engineer

Division Chemistry/Biotechnology

Contact Details:
JRomic-Pickl@wbetal.de

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Patentability criteria for biotechnological inventions

Biotechnology is red, white and green

Biotechnology can be subdivided into three main areas: The largest area is called “red biotechnology” and is applied in the healthcare and pharmaceutical sectors. The second area of “white biotechnology” relates to the use of microorganisms in chemical production systems. The third area of “green biotechnology” is about agriculture.

Biotechnological innovations have become indispensible for reaching the Sustainable Development Goals (SGDs) of the United Nations and the European Green Deal objectives. Thereby, new medical treatments, clean energy sources and sustainable agriculture are just three examples how biotechnology contributes to these goals.

Patentability criteria specific to the biotechnology field

As in other technology fields, biotechnological inventions can be patented, if they are new, inventive and industrially applicable. They must further fulfill the formal requirements of unity, clarity and sufficiency of disclosure. In addition to these general criteria, the European Patent Organisation´s member states have agreed on a number of special rules for inventions in the biotechnological field. These rules are in accordance with the EU Biopatent Directive and address rules about patentability of plants as well as patentability of genetically modified animals, and provide ethical and moral criteria for patenting in the biotechnological field, for instance.

In this article, we have reviewed the current Guidelines for Examination in the European Patent Office and the Case Law of the Boards of Appeal with a focus on patenting of biotechnological inventions. Using the most important keywords⁽¹⁾of the biotechnological area, we have summarized and linked the most important text passages relating to patenting in the biotechnological field in Tables 1 and 2.

Guidelines for Examination in view of biotechnological inventions

The current edition of the Guidelines for Examination in the European Patent Office (March 2023) includes several chapters and subchapters which address special features in the biotechnological area or are specifically dedicated to biotechnological inventions, and are summarized in Table 1.

Specific instructions for EPO patent examiners concerning applications including biological material can be found in A-IV, 4., E-IX, 2.4.4. and F-III, 6.. As biotechnological inventions often contain nucleotide and amino acid sequence information, the Guidelines for Examination dedicate several chapters to this topic (A-IV, 5., E-IX, 2.4.2., F-II, 6., F-IV, 4.24., G-III, 4.). Formal requirements on chemical formulae can be found in A-IX, 11..

Issues concerning patentable subject-matter of biotechnological inventions can be found in B-VIII, 2.1., G-II, 4./5., G-VI, 7./9., G-VII, 13.. Sufficiency of disclosure and unity of invention of biotechnological inventions are specifically considered in F-III, 6./9. and F-V, 3., respectively. F-IV 4.5.2 and F-IV 4.12. address rules on claim drafting with a focus on biotechnological inventions.

Table 1: Guidelines for Examination for biotechnological inventions. Chapters and subchapters related to the biotechnology field were identified searching for biotechnological keywords⁽¹⁾

Part A – Guidelines for Formalities Examination
Chapter	Focus on biotechnological inventions
IV – Special Provisions	4. Applications relating to biological material
IV – Special Provisions	5. Applications relating to nucleotide and amino acid sequences
IX – Drawings	11. Graphic forms of presentation not considered as Drawings ►11.1. Chemical and mathematical formulae
Part B – Guidelines for Search
Chapter	Focus on biotechnological inventions
VIII – Subject-matter to be excluded from the search	2. Considerations relating to specific exclusions from and exceptions to patentability ► 2.1. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body
Part E – Guidelines on General Procedural Matters
Chapter	Focus on biotechnological inventions
IX – Applications under the PCT	2. EPO as designated or elected Office ► 2.4.2 Sequence listings ► 2.4.4 Biological material
Part F – The European Patent Application
Chapter	Focus on biotechnological inventions
II – Content of a European patent application (other than claims)	6. Sequence listings
III – Sufficiency of disclosure	6. Inventions relating to biological material
III – Sufficiency of disclosure	9. “Reach through“ claims
IV – Claims	4. Clarity and interpretation of claims ► 4.5.2 Definition of essential features ► 4.12. Product-by-process claim ► 4.24. Interpretation of terms such as identity and similarity in relation to amino or nucleic acid sequences
V – Unity of invention	3. Assessment of unity ► 3.2.5 Markush grouping (alternatives in a single claim) ► 3.2.6 Claims for a known substance for a number of distinct medical uses ► 3.2.7 Intermediate and final products
Part G –Patentability
Chapter	Focus on biotechnological inventions
II – Inventions	4. Exceptions to patentability
II – Inventions	5. Exclusions and exceptions for biotechnological inventions
III – Industrial application	4. Sequences and partial sequences of genes
VI – Novelty	7. Examination of novelty
VI – Novelty	9. Novelty of “reach-through” claims
VII – Inventive step	13. Inventive step assessment in the field of biotechnology

Case Law of the Boards of Appeal in view of biotechnological inventions

The current tenth edition of the Case Law of the Boards of Appeal dedicates specific chapters, subchapters and sections to inventions in the biotechnological field, that are listed in Table 2.

In I-B of the Case Law, exceptions to patentability are specified. In chapter 2, the focus is set to breaches of “order public“ or morality, issues which may arise mainly in connection with biotechnological inventions (I-B 2.). One example is Case Law concerning elements isolated from the human body like sequences of a gene. Chapter 3 describes Case Law on patentability of plants/plant varieties (I-B 3.1.), animals/animal varieties (I-B 3.2.), essential biological processes for the production of animals and plants (I-B 3.3.) and microbiological processes and the products thereof (I-B 3.4.). In I-B 4., medical methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body, which shall not be granted, are addressed.

I-C 3. of the Case Law clarifies the availability of biological material to the public, and I-C 3.6.-8. specifically address issues about novelty of chemical inventions and first/second and further medical use, respectively.

In I-D 7-9., Case Law relating to the inventive step of biotechnological inventions is described.

Case Law II is about patent applications and amendments, and II-A 3.2. specifies clarity of claims, f.e. on diagnostic and surgical methods, whereas II-B 5.3. addresses the unity of claims, especially in the light of groups of chemical compounds.

In II-C on Case Law about sufficiency of disclosure, II-C 6.6.10 particularly addresses reproducibility of chemical compunds, and II-C 7. relates to sufficiency of disclosure in the biological field in particular.

Case Law laid down by the boards on the priority of inventions comprising nucleotide and amino acid sequences can be found in II-D 3.1.9.

II-E 1. focuses on Case Law on amendments with added subject-matter, with numerous specific biotechnological cases being listed in II-E 1.6.2 and II-E 1.6.3. II-E 2. describes Case Law on amendments with extension of the protection conferred. Specifically, in II-E 2.4.13 Case Law is laid down on narrowing down a generic list of chemical compounds.

Table 2: Biotechnological Case Law. Chapters, subchapters or sections related to the biotechnology field were identified searching for biotechnological keywords⁽¹⁾

CASE LAW – I Patentability
Chapter	Focus on biotechnological inventions
B – Exceptions to Patentability	2. Breaches of “ordre public” or morality
	3. Patentability of biological inventions
	4. Medical methods
C –Novelty	3. Availability to the public ► 3.2.5 Biological material
	6. Chemical inventions and selection inventions
	7. First and second medical use
	8. Second (and further) non-medical use
D – Inventive step	7. Expectation of success, especially in the field of genetic engineering and biotechnology
	8. Skilled person ► 8.1.3 Definition of the person skilled in the art in the field of biotechnology
	9. Assessment of inventive step ► 9.21.12 Animal testing and human clinical trials ► 9.9. Chemical inventions
CASE LAW – II Patent application and amendments
Chapter	Focus on biotechnological inventions
A – Claims	3. Clarity of claims ► 3.2. Indication of all essential features
B – Unity of Invention	5. The single general inventive concept ► 5.3. Unity of single claims defining alternatives (“Markush claims”)
C – Sufficiency of Disclosure	6. Reproducibility ► 6.6.10 Chemical compounds ► 7. The requirement of sufficiency of disclosure in the biological field
D – Priority	3. Identity of invention ► 3.1.9 Inventions relating to nucleotide and amino acid sequences
E – Amendments	1. Article 123(2) EPC – added subject-matter ► 1.6.2 Selections from two lists – singling out a combination of features ► 1.6.3 Deletion of elements from lists – shrinking the lists without singling out a combination of features
E – Amendments	2 Article 123(3) EPC – extension of the protection conferred ► 2.4.13 Narrowing down a generic class or list of chemical compounds

Taken together, in order to apply for a biotechnological patent numerous criteria specific to this area must be considered. Valuable sources for these criteria are the Guidelines for Examination and the Case Law of the Boards of Appeal. In this article, we have summarised the most important criteria for patents in biotechnology based on these two sources.

Our firm is characterised by a high level of commitment to advising founders on patent and trade mark law with regard to their innovative ideas and inventions.

Our concern is to protect innovations and to be your partner in the field of intellectual property.

Turning ideas into patents is an entrepreneurial decision based on weighing the expected strength of the invention, market potential and budget constraints.

We are pleased to offer you a free and non-binding initial consultation to get to know the law firm WINTER, BRANDL – Partnerschaft mbB and to clarify general questions!

We are looking forward to hearing from you. Please feel free to reach out to: CRegler@wbetal.de and JRomic-Pickl@wbetal.de.

⁽¹⁾ keywords of the biotechnological field: biological, biotechnology, sequences, medical, surgical, diagnostic, animal, plant, pharmaceutical, chemical

Dr. Julia Romic-Pickl

15.02.2024

Dr. rer. nat.

Patent Engineer

Division Chemistry/Biotechnology

Contact Details:
JRomic-Pickl@wbetal.de

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Women in IP

Innovations solve known and new challenges

Innovations form the basis for solving known and new challenges. Innovations are created by recognising problems and developing ideas to solve them. This involves rethinking previous assumptions and ways of solving problems. Ideas are realised in the form of new products or devices, as well as new technologies, methods and processes, and may be protected as intellectual property, for example in the form of patents.

The most important global challenges have been summarised in the Sustainable Development Goals (SDGs) by the United Nations (UN).¹ Health was given the highest priority by the UN member states. In this area innovations from the life sciences sector have already led to milestones in the fight against the world’s most common diseases. The health topic also includes new emerging challenges such as the recent coronavirus pandemic, for the containment of which highly effective mRNA-based vaccines were developed in record time.² Innovations are therefore indispensable for the general public. At the same time, they also create market value for the companies that develop them, if they are protected as intellectual property (IP), for example in the form of patents.

More women lead to more diverse teams and more innovation

How can more sustainable innovations be achieved? Several studies have dealt with this question. These studies came to the conclusion that new ideas and approaches are developed particularly frequently in mixed teams with a balanced proportion of women and men.³ Diverse teams incorporate different perspectives and have a better understanding of complex challenges, markets, customers and their needs. Mixed teams are not only more creative and generate more ideas, they also solve problems faster and generate more intellectual property in the form of patents.⁴ Therefore, mixed teams achieve better and more sustainable work results and are more innovative in the long term. Mixed teams are best equipped to provide solutions for existing and new challenges and are particularly future-proof and competitive.

Everyone benefits from more women in IP

Today, only 3 out of 10 jobs in science, technology, engineering and maths are held by women. Women are also underrepresented in the IP sector. This applies both to the proportion of women working in IP and to the proportion of women among inventors. For example, only 16% of international patent applications⁵ and only 13% of European applications⁶ are filed by women, even though women have a high degree of innovative and creative potential.

The basic prerequisite for diversity and equal opportunities is a corporate culture that promotes them. Our law firm, which offers family-friendly working time models and paid children´s sick days, is a good example therefore. Networks such as the Women in IP network and its mentoring programmes are also of central importance.⁷ It is thus important to create the conditions for social diversity to be reflected in the IP sector. This is a worthwhile goal, as it benefits everyone – not only women, but also companies and society.

References:

^{1 https://sdgs.un.org/goals}

^{2 https://wbetal.de/epa-insight-report-mrna-technologien/}

^{3 https://www.catalyst.org/research/why-diversity-and-inclusion-matter/}

^{4 https://hbr.org/2020/01/the-new-analytics-of-culture}

^{5 https://www.wipo.int/women-and-ip/en/}

^{6 https://www.epo.org/de/news-events/press-centre/press-release/2022/452251}

^{7 https://www.women-in-ip.com/}

Dr. Julia Romic-Pickl

7.12.2023

Dr. rer. nat.

Patent Engineer

Division Chemistry/Biotechnology

Contact Details:
JRomic-Pickl@wbetal.de

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The European Patent Office releases its latest biotechnological Insight Report on mRNA technologies

The European Patent Office (EPO) has released several Insight Reports since 2019 to inform about the latest important patent trends. Two of the ten Insight Reports released up to now relate to the biotechnology sector, which describe future and emerging technologies that are considered as groundbreaking in the medical sector. The present article focuses on the latest biotechnological Insight Report on mRNA-based vaccines, which is a particularly growing field of mRNA technologies.

Virus, RNA, Spritze — ^{/MattLphotography, Depositphoto.com}

mRNA technologies as important trend in biotechnology patents

mRNA technologies and mRNA-based vaccines in particular have the potential to fundamentally change the medical field in a wide range of applications aiming at preventing and treating several of the most widespread and lethal diseases worldwide including viral and bacterial infections, cancer and malaria. mRNA technologies are suited for the development of broad medical applications for the general public, as seen in the mRNA-based vaccines against SARS-CoV-2, which made a key contribution to containing the pandemic, as well as of tailormade medical applications like personalized cancer vaccines. Accordingly, mRNA technologies provide a flexible toolbox for preventing and treating a wide variety of human sufferings. In line with this, this year´s Nobel Prize in Physiology or Medicine and the EPO´s European Inventor Award 2022 has been awarded in the field of mRNA technology.

For the Insight Report, patent information drawn from the EPO´s databases of worldwide patent data was analysed. Comparing the number of inventions in the field of mRNA-based vaccines (termed by International Patent Families related to mRNA-based vaccines) with the total number of inventions across all fields of technology combined, a significantly higher increase rate was observed for mRNA-based vaccines over the last decade.

High proportion of International patent applications as indicator for high economic expectations

The highest amount of patent applications of mRNA-based vaccines take the international route that may result in patent protection in more than 150 countries worldwide, followed by US applications, EP applications, AU applications, CA applications, CN applications, and JP applications. The high proportion of International patent applications can be seen as indication of high economic expections and a corresponding multinational commercialisation strategy, as written in the Insight Report.

The importance of patents in biotechnology

Patents are legal rights which confer on patent holders the right to exclude others from comercially using the patented invention. Patents are likely to make a significant contribution to attract investment, secure licensing deals and provide market exclusivity, especially in the most IP-intensive sector of biotechnology, as shown in the recent EPO-EUIPO study „Patents, trademarks and startup finance“. In a nutshell, patents foster innovation, technology diffusion and economic growth.

Our firm is characterised by a high level of commitment to advising founders on patent and trade mark law with regard to their innovative ideas and inventions.

Our concern is to protect innovations and to be your partner in the field of intellectual property.

Turning ideas into patents is an entrepreneurial decision based on weighing the expected strength of the invention, market potential and budget constraints.

We are pleased to offer you a free and non-binding initial consultation to get to know the law firm WINTER, BRANDL – Partnerschaft mbB and to clarify general questions!

More detailed explanations and examples on this topic will follow shortly.

We are looking forward to hearing from you. Please feel free to reach out to: CRegler@wbetal.de and JRomic-Pickl@wbetal.de

Dr. Julia Romic-Pickl

29.11.2023

Dr. rer. nat.

Patent Engineer

Division Chemistry/Biotechnology

Contact Details:
JRomic-Pickl@wbetal.de

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