Main

The claims of a patent define the scope of protection for an invention, and are accordingly assessed in light of the existing knowledge when considering whether the invention complies with the requirements for patentability. Claims generally fall into two categories: the first refer to a physical entity, such as a product or apparatus; the second, to a process or use. It is permitted to use one or more categories of claim so as to adequately protect an invention, provided that both claim types embody the same inventive concept. Within these categories are various sub-categories in which the claim will be defined in terms of its technical content in the context of a particular field or area of interest, such as, for example, a pharmaceutical composition having a defined structure. Similarly, if a new use has been identified for the pharmaceutical compound it is possible to claim that new use.

Exclusions

For an invention to be patentable in Europe it must possess a technical character, and the European Patent Convention (EPC) lists examples of those inventions that are considered to lack such character. These include mathematical methods, rules and methods for performing mental acts or doing business, the presentation of information, or computer programs as such. There is a considerable amount of case law to determine whether a claim constitutes one or more of the exclusions.

Methods of treatment of the human or animal body, such as surgery, therapy or diagnostic methods, are also excluded from patentability, but this does not apply to products for use in such methods. Again, whether any given method will be allowable is decided on a case-by-case basis, but there are many previous cases on the matter which provide guidance.

One of the overriding considerations is that a medical practitioner should not be prevented or otherwise impeded from performing his or her medical duties by virtue of the existence of patents. However, it is possible to use a particular form of claim known as the 'first or second medical use' type claim, which can provide protection to the new use of a known composition (see box).

Other exceptions to patentability include those inventions that are considered contrary to 'ordre public'. Morality issues are often used by third parties to object to what they might view as morally questionable patents; for example, patents on transgenic animals. However, patents are negative rights that do not confer on the patentee the right to work the invention but only to prevent others from doing so. Therefore, if legislation exists, for example, to prevent human cloning, obtaining a patent that might embrace such cloning will not constitute a licence to allow the patentee to conduct research in that area.

Human cloning

Patents should, however, never be granted in this area in Europe in view of a European Directive on the legal protection of biotechnical inventions, the main provisions of which have also been incorporated into the EPC. The new rules outline the exceptions to patentability — including processes for cloning human beings, certain uses of human embryos and processes for modifying the germline genetic identity of human beings as well as animals — that are likely to cause suffering to the animal without any substantial benefit to humankind. The Directive was introduced to harmonize the law in each state of the European Union regarding patentability of inventions in the biotechnology field, although some member states have yet to comply.

Plants and animals

Patents on plants or animals are permissible if the technical feasability of the invention is not limited to a particular plant or animal variety, by virtue of of the European Directive described above. However, it remains to be seen whether claims to transgenic plants and animals will be upheld in those states that have not yet implemented the Directive.

Gene sequences

Parts of the human body, including the sequence or partial sequence of a gene, are not patentable unless isolated from the human body or produced by means of a technical process. For DNA sequences this requirement is in practice irrelevant because all DNA sequences will generally have to be isolated or otherwise produced by means of a technical process for the sequence to be determined. However, it is also stipulated that the industrial application of a gene must be disclosed in the patent application. In other words, it will no longer be sufficient to merely supply the sequence of a new gene for it to be patentable. Its function must also be supplied, along with a description of how it is to be used. This function must be substantial and credible on the basis of the experimental evidence provided in the application. If the function supplied in the patent application is found to be incorrect, the applicant risks those claims that rely on such function to confer industrial applicability being declared invalid.