Biotechnology patents
Produced in partnership with Nicole Jadeja and Chris Leung of Fieldfisher
Biotechnology patents

The following Life Sciences practice note produced in partnership with Nicole Jadeja and Chris Leung of Fieldfisher provides comprehensive and up to date legal information covering:

  • Biotechnology patents
  • What is biotechnology
  • The current regulatory framework for biotechnology patents
  • What may be patented
  • What cannot be patented
  • Article 4—Plant and animal varieties and ‘essentially biological’ processes
  • Article 5—The human body and the simple discovery of one of its elements
  • Article 6—Inventions contrary to ordre public or morality
  • The exclusion under Article 53(b) of the EPC
  • Court of Justice decisions regarding biotechnology patents
  • More...

IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements come to an end and significant changes begin to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for Life Sciences?

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

What is biotechnology

Biotechnological inventions are defined in Rule 26(2) of the European Patent Convention (EPC) as:

‘inventions which concern a product consisting of or containing biological material or a process

by means of which biological material is produced, processed or used.’

Biological material is further defined in Rule 26(3) as:

‘any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.’

Biotechnological inventions are, in principle, patentable. While there is no general exclusion against them in the Patents Act 1977 (PA 1977) or the EPC, there are specific rules governing the patentability of such inventions (see: The current regulatory framework for biotechnology patents below). Further, in practice, certain biotechnological inventions, while not necessarily specifically excluded, may fall foul of the usual requirements for novelty, inventive step and industrial applicability.

The majority of biotechnology patents are granted for pharmaceutical innovations and industrial processes, although some are also granted in the field of agriculture. Examples of patented biotechnological inventions include tests to screen donated blood for the presence of viruses and gene sequences isolated from the human body which form the basis of biopharmaceuticals.

The current regulatory framework for biotechnology patents

Biotechnology inventions may be patented and are subject to the same rules as other inventions but in addition are governed by Directive 98/44/EC, the Biotechnology Directive.

The Biotechnology Directive was introduced because of concerns about the patentability of inventions involving biological material and processes and the different approaches taken to those inventions across the EU. Its purpose is to ensure that, provided the usual conditions of patentability are met, biotechnological inventions are protected under patent laws of the Member States of the EU and to harmonise the approach to such protection.

The Biotechnology Directive was adopted on 6 July 1998 and was incorporated into the EPC in 1999. The effect of its incorporation into the EPC is that patents processed through the European Patent Office (EPO) are subject to the provisions of the Biotechnology Directive.

Articles 1–11 of the Biotechnology Directive were incorporated into UK national law by the Patents Regulations 2000, SI 2000/2037, which inserted into PA 1977 a new section 76A and Schedule A2.

What may be patented

Article 3(1) of the Biotechnology Directive provides that:

'For the purpose of this directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of, or containing biological material, or a process by which biological material is produced, processed or used.'

Article 3(2) further makes clear that isolated biological material (for example gene sequences) may be the subject of a patent:

'Biological material which is isolated from its natural environment or produced by means of a technical process may be subject of an invention even if it previously occurred in nature.'

Article 3 of the Biotechnology Directive is mirrored in part by PA 1977, Sch A2, paras 1–2.

What cannot be patented

Pursuant to Articles 4–6 of the Biotechnology Directive, certain biotechnological inventions are not patentable. The equivalent UK provisions are contained within PA 1977, Sch A2, paras 3–5.

Article 4—Plant and animal varieties and ‘essentially biological’ processes

Article 4 of the Biotechnology Directive provides that the following are not patentable:

  1. plant and animal varieties, and

  2. ‘essentially biological’ processes for the production of plants or animals

Article 2(2) of the Biotechnology Directive defines a process for the production of plants or animals as ‘essentially biological’ if it consists entirely of natural phenomena such as crossing or selection. This definition for ‘essentially biological’ has been the subject of several EPO decisions and a Notice from the European Commission (see ‘The exclusion under Article 53(b) of the EPC’ below).

The exclusions in Article 4 are subject to two provisos.

First, 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. However, plant varieties are protectable in the UK by plant breeders' rights, which were first introduced by the Plant Varieties and Seeds Act 1964. They are granted by the Plant Rights Variety Office pursuant to the Plant Varieties Act 1997. The UK regime co-exists with that created by Regulation (EC) 2100/94 on Community plant variety rights, which allows for the grant of harmonised EU-wide plant variety rights by the Community Plant Variety Office. For more information about plant breeders' rights, see Practice Note: Plant variety rights and other plant-related IP protection.

Second, the prohibition against patenting ‘essentially biological’ processes does not apply to inventions which concern a microbiological or other technical process, or a product obtained by means of such a process. The current practice of the EPO is to define ‘micro-organism’ broadly so that it includes not only bacteria and yeasts, but also fungi, algae, protozoa and human, animal and plant cells, ie ‘all generally unicellular organisms with dimensions not visible to the naked eye which can be propagated and manipulated in a laboratory, including plasmids and viruses’. According to EPO decision in Case T 0356/93 (Plant cells), which addresses the EPC provision dealing with ‘essentially biological’ processes, the concept of ‘microbiological processes’ refers to processes in which micro-organisms, or their parts, are used to make or modify products, or in which new micro-organisms are developed for specific uses. ‘Products’ of such processes therefore encompass products which are made or modified by micro-organisms, as well as new micro-organisms as such.

Article 5—The human body and the simple discovery of one of its elements

Article 5 of the Biotechnology Directive specifically excludes from patentability the human body at various stages of its development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. This means patents may be granted for biopharmaceuticals based on antibodies or other gene sequences, such as Humira, which contains the human monoclonal antibody adalimumab.

Article 6—Inventions contrary to ordre public or morality

If the commercial exploitation of an invention would be 'contrary to ordre public or morality', Article 6(1) of the Biotechnology Directive provides that the invention is to be considered unpatentable. Specific examples of such inventions given in Article 6(2) of the Biotechnology Directive are:

  1. processes for cloning human beings

  2. processes for modifying the germ line genetic identity of human beings

  3. use of human embryos for industrial or commercial purposes

  4. processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to humans or animals

The exclusion under Article 53(b) of the EPC

Article 53(b) of the EPC provides the following exclusion from patentability:

‘Plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof.’

This exclusion was incorporated into the EPC to reflect the provisions introduced by Article 4(b) of the Biotechnology Directive. This exclusion was also reproduced in PA 1977, Sch A2, para 3(f).

There has been debate over the scope of this exclusion, specifically over whether products produced by essentially biological processes are excluded from patentability. While the Enlarged Board of Appeal of the EPO has held that such products are not excluded from patentability, the European Commission has issued a Commission Notice to the contrary, see: EPO case law concerning the exclusion under Article 53(b) of the EPC and Commission notice on biotechnological inventions below.

Court of Justice decisions regarding biotechnology patents

As an instrument of the EU, interpretation of the Biotechnology Directive is a matter for the Court of Justice through references from the courts of the Member States. Two references to the Court of Justice have provided guidance to the meaning of the Biotechnology Directive.

Monsanto v Cefetra BV (Case C-428/08)

This case, which was referred by the Hague Rechtbank (a District Court of the Netherlands), concerned a patent protecting a product containing or consisting of genetic information and the conditions for protecting material incorporating the product. It involved the interpretation of Article 9 of the Biotechnology Directive and the circumstances in which a product containing genetic information, which is the subject of a patent, may infringe that patent.

The background to the case was an action brought by Monsanto against a number of companies for infringement of a Dutch part of a European patent. The patent described a class of enzymes which are not sensitive to glyphosate, a weedkiller. Plants containing these enzymes survive contact with glyphosate while weeds are destroyed. Monsanto had inserted the genes encoding for these enzymes, which had been isolated from bacteria, into the DNA of soy plants. The resulting plants produce one of the class of enzymes and are resistant to glyphosate weedkillers. Soy beans with this feature are grown in Argentina where there is no patent protection covering the material. A number of companies had imported soy meal into the Netherlands (and other Member States). Tests of samples of the soy meal conducted by Monsanto established the presence in the meal of the glyphosate resistant enzyme and the DNA sequence encoding for it. On the basis of this information, Monsanto brought patent infringement proceedings in the Netherlands against the companies importing the soy meal containing that material.

The court in the Netherlands was satisfied that the material imported into the Netherlands contained the enzyme and its DNA sequence protected by Monsanto’s patent. The question for the Court of Justice was whether the presence of the enzyme and DNA sequence in soy meal marketed in jurisdictions in which the patent was valid was sufficient to infringe the patent. The Court of Justice held that it was not.

Article 9 of the Biotechnology Directive provides that:

‘The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material...in which the product is incorporated and in which the genetic information is contained and performs its function.’

The Court of Justice held that this article should not be interpreted

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