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Legislative Implementation of Flexibilities - United Kingdom

Title:Section 1 (2) (a) and 76A and Schedule A2 (Section 76) (1)-(6) and (11) of the Patents Act of 1977, consolidated version of 01/01/2010
Field of IP:Patents
Type of flexibility:Patentability of substances existing in nature
Summary table:PDF

Provisions of Law

Patentable inventions

1.-(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, that is to say, anything which consists of -

(a) a discovery, scientific theory or mathematical method;

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.

Schedule A2 (section 76A)

Biotechnological inventions

1. 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.

2. 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.

3. The following are not 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.

4. 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.

5. 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.

6. The industrial application of a sequence or partial sequence of a gene must be disclosed in the patent application as filed.

11. In this Schedule:

"essentially biological process" means a process for the production of animals and plants which consists entirely of natural phenomena such as crossing and selection;

"microbiological process" means any process involving or performed upon or resulting in microbiological material;

"plant variety" means a plant grouping within a single botanical taxon of the lowest known rank, which grouping can be:

(a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes; and

(b) distinguished from any other plant grouping by the expression of at least one of the said characteristics; and

(c) considered as a unit with regard to its suitability for being propagated unchanged.