Section 76A: Biotechnological inventions

Sections (76A.01 - 76A.10) last updated: January 2024.

76A.01

This section was introduced by the Patents Regulations 2000 (SI 2000/2037), which implemented articles 1-11 of Directive 98/44/EC on the legal protection of biotechnological inventions. The Patents Act 1977 (Isle of Man) Order 2003 (SI 2003/1249) brought this section into force in the Isle of Man.

[The Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the Intellectual Property Office provide further details on practice in this field.]

76A.01.1

Under the provisions of the European Union (Withdrawal) Act 2018 (“the Withdrawal Act”), EU-derived domestic legislation and direct EU legislation in force in the UK at 11pm on 31 December 2020 was saved or incorporated into domestic law. This includes the Patents Regulations 2000, which continues to have effect as assimilated law under section 2 of the Withdrawal Act. As it is not direct EU legislation, Directive 98/44/EC no longer has effect in the UK; however, it remains relevant for interpreting the provisions as implemented in UK law, as does case law of the Court of Justice of the European Union issued before 31 December 2020, as set out in section 6 of the Withdrawal Act. Courts and tribunals below the level of the Court of Appeal remain bound to follow the principles and interpretations provided by this assimilated case law, as is the Office - in particular, as it relates to the processing and examination of patent applications.

Section 76A(1)

Any provision of, or made under, this Act is to have effect in relation to a patent or an application for a patent which concerns a biotechnological invention, subject to the provisions of Schedule A2.

Patentability of biotechnological inventions

Sch. A2 paras 1 & 3 is also relevant.

76A.02

The provisions of Schedule A2 to the Patents Act 1977 (as amended) repeat and paras 1& 3 expand upon the exclusions from patentability for animals, plants and biological processes that were contained in s.1(3)(b) of the Act before it was repealed by the Patents Regulations 2000 (see 1.41-1.46). The Schedule states that an invention shall not be considered unpatentable solely on the ground that it concerns (a) a product consisting of or containing biological material; or (b) a process by which biological material is produced, processed or used (the definition of “biological material” being inserted into s.130(1) - see 130.04.1). However, it then sets out the following as not being patentable inventions:

(a) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene;

(b) processes for cloning human beings;

(c) processes for modifying the germ line genetic identity of human beings;

(d) uses of human embryos for industrial or commercial purposes;

(e) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes;

(f) any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process.

76A.02.1

In C-34/10 (“Brüstle”), the Court of Justice of the European Union (CJEU) ruled on the interpretation of Article 6(2)(c) of Directive 98/44/EC, which corresponds with paragraph 3(d) of Schedule A2 of the Act. The CJEU ruled that, for the purposes of Article 6(2)(c), the term “human embryo” must be interpreted broadly to include any organism that is “capable of commencing the process of development of a human being”. In paragraphs 35-38 the

CJEU held that the term “human embryo” included:

• any human ovum after fertilisation, if that fertilisation is such as to commence the process of development of a human being;
• a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, insofar as it is capable of commencing the process of development of a human being;
• a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis, insofar as it is capable of commencing the process of development of a human being.

In C-364/13 (“International Stem Cell Corporation”), the CJEU further clarified the definition of the term “embryo” for the purposes of Article 6(2)(c) of the Directive, by ruling that:

an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’ within the meaning of that provision [i.e. Article 6(2)(c) of the Directive], if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being.

76A.02.2

In light of the aforementioned decisions, the examination practice for inventions involving human embryonic stem cells is set out below, with the term “human embryo” interpreted in accordance with those decisions:

(i) Processes for obtaining stem cells from human embryos
The Office will not grant patents for processes of obtaining stem cells from human embryos because they involve the use of human embryos for industrial or commercial purposes, as excluded under paragraph 3(d) of schedule 2 of the Act.

(ii) Human totipotent cells

Human totipotent cells have the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from patentability by paragraph 3(a) of Schedule A2 to the Act. The Office will therefore not grant patents for human totipotent cells.

(iii) Inventions requiring the destruction of human embryos

In Brüstle, the CJEU ruled that use of human embryos within the meaning of Article 6(2)(c) of the Directive occurs if the implementation of the invention requires the destruction of human embryos, even if the claims of the patent do not refer to the use of human embryos. The CJEU also ruled that the destruction may occur at any stage, including long before the implementation of the invention. Thus, where the implementation of an invention requires the use of cells that originate from a process which requires the destruction of a human embryo, the invention is not patentable according to paragraph 3(d) of Schedule A2 to the Act. For example, where the implementation of the invention requires the use of a human embryonic stem cell line, the establishment of which originally required the destruction of a human embryo, the invention is not patentable.

(iv) Human stem cells not derived from human embryos

Patents for inventions concerning human stem cells that are not derived from human embryos, such as induced pluripotent cells and adult stem cells, will be granted, provided they satisfy the other requirements for patentability.

(v) Inventions for therapeutic or diagnostic purposes

The CJEU judgment in Brüstle confirmed that inventions that are for therapeutic or diagnostic purposes that are applied to and useful to the human embryo are not excluded from patentability. The Office will continue to grant patents for such inventions, provided they meet the other legal requirements.

Further details of examination practice in relation to inventions involving human embryonic stem cells can be found in the Practice Notice dated March 2015.

76A.02.3

In the Harvard “oncomouse” case T 315/03 ([2006] 1 OJEPO 15, [2005] EPOR 31), the EPO Board of Appeal held that an assessment of an objection to patentability under r.23 (d) EPC [1973] (the corresponding provisions of subparagraphs (b) to (e)) is to be made as of the filing or priority date of the patent application; evidence arising after this date may be taken into account provided it is directed to the position at that date. The Board held that when assessing the factors in subparagraph (e), only three matters should be considered: animal suffering, medical benefit and the necessary correspondence between the two in terms of the animals in question. The level of proof required is the same for both animal suffering and substantial medical benefit, namely a likelihood. In this case, claims covering transgenic rodents were refused as there was no evidence of substantial medical benefit deriving from applying the claimed process to all rodents. However, the Board allowed claims restricted to “mice”, considering that the likelihood of substantial medical benefit in relation to advances in cancer research was relevant to all members of the mouse family, and there was clear correspondence between the medical benefit and the animal suffering.

76A.03

The wording of subparagraph (f) closely follows that of the repealed s.1(3)(b) - see 1.46. Whether or not a (non-microbiological) process for the production of animals or plants is to be considered as “essentially biological” has to be judged on the basis of the essence of the invention taking into account the totality of human intervention and its impact on the result achieved. However, the necessity for human intervention alone is not a sufficient criterion for an invention not being “essentially biological”. The EPO Enlarged Board of Appeal in two related decisions (G 02/07 and G 01/08) held that claims to any non- microbiological processes for the sexual crossing of the whole genomes of plants are excluded as being “essentially biological”. Furthermore, claims to a breeding process do not escape the exclusion merely by the addition of a further technical step which serves to enable or assist the the steps of sexually crossing or subsequently selecting the offspring. This is because such steps do not move the process beyond what is considered to be “essentially biological” processes. Therefore, in order to be patentable at least one additional technical step must be performed within the steps of sexual crossing and selection, which “by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing”.

76A.03.1

76A.03.1 In G2/12 and G 2/13, the Enlarged Board of Appeal found that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material such as plant parts. Furthermore, a product-by-process claim directed to plants or plant material (and not limited to a plant variety), wherein the process features define an essentially biological process for the production of plants, was not considered to be unpatentable under Article 53(b) EPC. In these decisions, the Enlarged Board found that a claim is also not excluded merely because of the fact that the only method available at the filing date for generating the claimed subject matter is an essentially biological process. However, in the later decision G 3/19 the Enlarged Board reversed the earlier decisions made in G2/12 and G 2/13 and gave its view that the exclusion of essentially biological processes under Article 53(b) EPC does have a negative effect on the allowability of product claims and product-by-process claims directed to plants, plant material, or animals, if the claimed product is obtained exclusively by an essentially biological process or if the claimed process features in a product-by-process claim define an essentially biological process.

76A.04

As subparagraph (f) makes clear, the exclusion does not apply to micro-biological or other technical processes or the products thereof, and patents may therefore be obtained not only for processes involving micro-organisms, but also for micro-organisms themselves (as well as inanimate products) when produced by a micro-biological process. “Micro- biological or other technical processes” should be construed widely as including selective culturing or cross-breeding of micro-organisms including sub micro-organisms and not be restricted to essentially chemical manufacturing processes in which micro-organisms are used. Thus a claim to micro-organisms per se may be allowed when they have been obtained by cross-selecting from known micro-organisms, by artificial mutation or by micro- biological reproduction processes in which normal conditions have been altered by human intervention.

76A.05

Sch. A2 para 4 is also relevant.

Inventions which concern plants or animals may be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. The EPO Enlarged Board of Appeal in Novartis/Transgenic plant G1/98 ([2000] EPOR 303; [2000] 3 OJEPO 111) has stated that a claim in which specific varieties are not individually claimed is not excluded from patentability under a.53(b) EPC (equivalent to Sch A2 para 3(f)) even if the claim embraces within its scope plant varieties. (Certain plant varieties are capable of protection in the UK under the Plant Varieties and Seeds Act 1964, which is administered by the Plant Variety Rights Office, White House Lane, Huntingdon Road, Cambridge CB3 OLF). The scope of the exclusion of animal varieties was considered by the EPO in the Harvard “oncomouse” case T 315/03 ([2006] 1 OJEPO 15, [2005] EPOR 31). Here it was held that the principle enunciated in G1/98 concerning plant and plant varieties should be followed in the case of animals: a patent should not be granted for a single animal variety (or species or race, depending on which language text of the EPC is used) but can be granted if varieties may fall within the scope of its claims. The Board pointed out the inconsistency in taxonomical rank between variety, species and race, with the German term “Tierarten” (i.e. “animal species”) having the highest taxonomical order, but it concluded that mice constituted a taxonomic classification broader than species, and therefore claims to transgenic mice were not excluded from patentability under a.53(b) EPC. (see also 1.43).

76A.06

Sch. A2 paras 2, 5 Sch. A2 para 6 is also relevant.

Finding biological material, such as a micro-organism, occurring freely in nature is a mere discovery and is therefore unpatentable as such (see 1.27-1.28). However, biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention, even if the material previously occurred in nature. More specifically, following the Relaxin case (Howard Florey Institute of Experimental Physiology [1995] 6 OJEPO 388 (V 08/94), the Schedule states that an element isolated from the human body or otherwise produced by means of a technical process may be patentable even if the structure of that element is identical to that of the natural element. This includes the sequence or partial sequence of a gene. However, where the invention in a patent application resides in a whole or partial gene sequence, the industrial application of the sequence must be disclosed in the application as filed – see 4.07.1-2.

Construction of claims relating to biotechnological inventions

76A.07

Sch. A2 para 7 Sch.A2 para 8 Sch. A2 para 9 Sch. A2 para 10 ss.60(5) &(6A)-(6C) is also relevant.

Paragraphs 7 to 10 of Schedule A2 set out certain rules for the construction of claims which relate to biological material or to processes that enable biological material to be produced. In particular, a claim to a biological material which has certain specific characteristics as a result of the invention is construed as extending to protect biological material possessing the same specific characteristics which has been derived from the claimed material by propagation or multiplication. Similarly, a claim to a process for producing biological material which has certain specific characteristics as a result of the invention is construed as extending to protect the biological material itself and to biological material possessing the same specific characteristics which has been derived from that material by propagation or multiplication.

76A.08

Paragraph 9 of Schedule A2 (derived from Article 9 of Directive 98/44/EC) states that a claim to a product containing or consisting of genetic information is construed as extending to all material (except excluded material - see 76A.02) in which the product is incorporated and in which the genetic information is contained and performs its function. The interpretation of Article 9 of the Directive was considered by the European Court of Justice in Monsanto Technology LLC v Cefetra BV et al ECJ Case C-428/08. This was a reference from the Dutch courts on a case concerning the import of soy meal derived from genetically modified soybeans. The soy meal was found to contain a modified gene; this modified gene, and plants and plant cells containing it, were covered by a valid European patent held by Monsanto. The DNA in the soy meal was clearly not “performing its function”, as the soy meal was dead, but it had performed its function (of protecting the plant against a herbicide) in the living plant from which the soy meal was derived, and could conceivably do so again if it was extracted and transferred to a living plant or cell.

76A.08.1

The ECJ held that patent protection for genetic material does not extend to circumstances where the genetic material has ceased to perform its function, even if it did perform this function in the past and could possibly do so in the future if isolated and transferred into a living cell. Moreover, Article 9 of the Directive precludes national patent law from offering absolute protection to the patented genetic material, regardless of whether it performs its function in the material containing it. This has implications for the interpretation of s.60 in the case of biotechnological inventions. Section 60(1)(a) states that where the invention is a product, it is an infringement to make, dispose of, offer to dispose of, use or import the product or keep it whether for disposal or otherwise (see 60.06-16). However, if the product contains or consists of genetic material, this is subject to the proviso that it performs its function in the material containing it. In other words, s.60 must be read in the light of paragraph 9 of Schedule A2 for inventions of this type, and it may be inferred that the same applies for all of paragraphs 7-10 of Schedule A2. In addition, the ECJ held that it was irrelevant whether the patent had been filed or granted before adoption of the Directive, and that the interpretation of Article 9 is not affected by the provisions of the TRIPS Agreement.

76A.09

Where biological material which is subject to patent protection is put on the market by the proprietor (or with their consent), and where propagation or multiplication of further biological material necessarily results, the protection conferred by the patent does not extend to this further biological material, provided that this further material is not then used for further propagation or multiplication. (Under certain limited circumstances, however, it is possible for farmers to use this further material for further propagation or multiplication without infringing - see 60.26-27).

Section 76A(2)

Nothing in this section or Schedule A2 is to be read as affecting the application of any provision in relation to any other kind of patent or application for a patent.

76A.10

Section 76A(2) makes clear that the provisions of this section and of Schedule A2 cannot be construed as having any effect on a patent or application which does not concern a biotechnological invention. The Patents Regulations 2000 added to s.130(1) a definition of what constitutes a ‘biotechnological invention’ - see 130.04.1.