Patents

Biotechnological Inventions

John Lambert

3 May 2000.
Last updated 14 April 2004
This article formerly appeared on the Old Colony House website

The Patents Regulations 2000 (SI 2000 No: 2037) ("the regulations") implement Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions ("the directive") by amending the Patents Act 1977 ("the Act") with effect from 28 July 2000. The regulations (dated 27 July 2000) are made pursuant to section 2 (2) and (4) of the European Communities Act 1972. The directive and the regulations are interesting legislative instruments in that they balance the commercial exigency of protecting investment in biological and biotechnological research against "the fundamental principles safeguarding the dignity and integrity of the person."
Background

The directive recites that differences exist in the legal protection of biotechnological inventions between member states that could create barriers to trade and impede the proper functioning of the internal market. Such differences threaten to become greater were member states to adopt new and different legislation and administrative practices and national case law to develop differently. However, the directive also recites that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person and that it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, and the simple discovery of one of its elements or one of its products, including the sequence or partial sequence of a human gene, cannot be patented.

Members' Obligations under TRIPS

Art 27 (1) of the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") requires patents to be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve and inventive step and are capable of industrial application. However, para (2) of that article permits World Trade Organization member countries to exclude certain inventions from patentability on grounds of ordre public or morality where it is necessary to protect human, animal or plant life or health or to avoid serious prejudice to the environment provided that such exclusion is not made merely because the exclusion is not made merely because the exploitation is prohibited by their law. Members are also entitled to exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and
(b) plants and animals other than micro-organisms, and essentially biological processes, for the production of plants or animals other than non-biological and microbiological processes.

Member countries are required to protect plant varieties either by patents, an effective sui generis system or a combination of the two.

Exclusions from the Definition of "Patentable Invention" in the Act
S. 1 (1) of the Act provides that a patent may be granted for an invention in respect of which certain conditions are satisfied. One of those conditions by virtue of s.1 (1) (d) is that a patent for the invention is not excluded by s.1 (2) and (3). Before its amendment by the Regulations, s.1 (3) prohibited the grant of a patent for:

(a) an invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour; and
(b) any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process.

S.1 (4) added that for the purposes of s.1 (3) above, behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in the United Kingdom or any part of it. Interestingly, s.1 (5) provided for the Secretary of State to vary by statutory instrument the declaration excluding from patentability discoveries, scientific theories, mathematical methods, literary, dramatic, musical or artistic works, schemes, rules or methods for performing a mental act, playing games, doing business or computer programs and the presentation of information as such for the purpose of maintaining them in conformity with developments in science and technology but there was no corresponding provision for varying the exclusions under s.1 (3). 
The Directive

Art 1 of the directive requires member states to protect biotechnological inventions under national patent law, if necessary, by adjusting such law to take account of the provisions of the directive with effect from the 30 July 2000. Inventions that are new, involve an inventive step and susceptible of industrial application are patentable pursuant to art 3 (1) even if they 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`, for these purposes, is defined in art 2 (1) (a) as "any material containing genetic information and capable of reproducing itself or being reproduced in a biological system." Art 3 (2) further provides that 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 it previously occurring in nature.

However, art 4 (1) excludes plant and animal varieties and essentially biological processes for the production of plants or animals although inventions which concern plants or animals are to be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. This is without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process.

'Microbiological process', in this context, means any process involving or performed upon or resulting in microbiological material. Also excluded from patentability by virtue of art 5 (1) is 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. 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.
Art 6 (1) requires inventions to be considered un-patentable where their commercial exploitation would be contrary to ordre public or morality though exploitation is not to be deemed to be so contrary merely because it is prohibited by law or regulation. Particular inventions that are excluded on these grounds are:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) 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.
This area is kept under review by the European Group on Ethics in Science and New Technologies.
Amendments to the Definition of "Patentable Invention"
Reg 3 of the regulations amends s.1 (3) and (4) of the Act by substituting new sub-sections (3) and (4). The new s.1 (3) prohibits the grant of a patent for an invention the commercial exploitation of which would be contrary to public policy or morality. However, the new s.1(4) provides that for the purposes of s.1 (3) "exploitation shall not be regarded as contrary to public policy or morality only because it is prohibited by any law in force in the United Kingdom or any part of it." The previous reference to offensive, immoral or anti-social behaviour is dropped bringing the language of the Act in line with article 27 (2) of TRIPs.
Regulation 5 inserts a new section 76A:

" Biotechnological inventions
 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.

(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.".

Para 1 of Sched 2A provides that an invention shall not be considered un-patentable 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."
Para 2 provides that 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 it previously occurred in nature. However, para 3 excludes from patentability:
(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; and 
(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.
Para 4 of Sched 2A provides that 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. 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 by virtue of para 5.

Protection of Inventions covered by the Act as amended by the Regulations

Paras 7 to 10 of the new Sched 2A apply articles 8 and 9 of the directive.  The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics by virtue of para 7. Para 8 provides that the protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material derived from the directly obtained biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics. Para 9 extends the protection conferred by a patent on a product containing or consisting of genetic information to all material, save as provided for in para 3 (a), in which the product is incorporated and in which the genetic information is contained and performs its function.   However, para 10  provides that such patent protection shall not extend to biological material obtained from the propagation or multiplication of biological material placed on the market by the proprietor of the patent or with his consent, where the multiplication or propagation necessarily results from the application for which the biological material was marketed, provided that the material obtained is not subsequently used for other propagation or multiplication.

Defences

In order to give effect to arts 10 and 11 of the directive which limit the protection conferred by patents for inventions covered by that directive, reg 4 adds the following to the list of acts in s. 60 (5) of the 1977 statute that do not constitute an infringement of a patent:

"(a) it consists of the use by a farmer of the product of his harvest for propagation or multiplication by him on his own holding, where there has been a sale of plant propagating material to the farmer by the proprietor of the patent or with his consent for agricultural use; 
(b) it consists of the use of an animal or animal reproductive material by a farmer for an agricultural purpose following a sale to the farmer, by the proprietor of the patent or with his consent, of breeding stock or other animal reproductive material which constitutes or contains the patented invention."

However, a new s.60 (6A) of the Act provides for para (g) to be subject to certain provisions in a new Sched A1 restricting the circumstances in which it applies. Para 2 of that Sched applies s.60 (5) (g) only to specified varieties of plant species and groups. If a farmer's use of protected material is authorized by s.60 (5) (g), para 3 (1) requires him at the time of use to pay the relevant rights holder equitable remuneration. For the purposes of s.60 (5) (h), a new s.60 (6B) includes within the definition of "use for an agricultural purpose" making an animal or animal reproductive material available for the purposes of pursuing the farmer's agricultural activity." The definition does not "include sale within the framework, or for the purposes, of a commercial reproduction activity." "Sale", for these purposes, includes any other form of commercialisation."

Other Provisions

Para 6 of the new Sched 2A requires the industrial application of a sequence or partial sequence of a gene to be disclosed in the patent application as filed. There are various consequential amendments to s.125A and s. 130 of the Act. 

Effective Date
Reg 9 applies these amendments to applications for patents made on or after the 28 July 2000.

 

Important