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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
ChapterFocus on biotechnological inventions
IV – Special Provisions4. Applications relating to biological material
5. Applications relating to nucleotide and amino acid sequences
IX – Drawings11. Graphic forms of presentation not considered as Drawings
►11.1. Chemical and mathematical formulae
Part B – Guidelines for Search
ChapterFocus on biotechnological inventions
VIII – Subject-matter to be excluded from the search2. 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
ChapterFocus on biotechnological inventions
IX – Applications under the PCT2. EPO as designated or elected Office
► 2.4.2 Sequence listings
► 2.4.4 Biological material
Part F – The European Patent Application
ChapterFocus on biotechnological inventions
II – Content of a European patent application (other than claims)6. Sequence listings
III – Sufficiency of disclosure6. Inventions relating to biological material
9. “Reach through“ claims
IV – Claims4. 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 invention3. 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
ChapterFocus on biotechnological inventions
II – Inventions4. Exceptions to patentability
5. Exclusions and exceptions for biotechnological inventions
III – Industrial application4. Sequences and partial sequences of genes
VI – Novelty7. Examination of novelty
9. Novelty of “reach-through” claims
VII – Inventive step13. 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
ChapterFocus on biotechnological inventions
B – Exceptions to Patentability  2. Breaches of “ordre public” or morality
3. Patentability of biological inventions
4. Medical methods
C –Novelty3. 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 step7. 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
ChapterFocus on biotechnological inventions
A – Claims3. Clarity of claims
► 3.2. Indication of all essential features
B – Unity of Invention5. The single general inventive concept
► 5.3. Unity of single claims defining alternatives (“Markush claims”)
C – Sufficiency of Disclosure6. Reproducibility
► 6.6.10 Chemical compounds
7. The requirement of sufficiency of disclosure in the biological field
D – Priority3. Identity of invention
► 3.1.9 Inventions relating to nucleotide and amino acid sequences
E – Amendments1. 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
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.

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