Pharmaceutical IP and Competition Law in Ireland
This is a Q&A guide to pharmaceutical IP and competition law in Ireland.
What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?
Conditions and legislation
Medicinal products and related substances, as well as the processes for their production, can be patent protected, provided they meet certain criteria.
The relevant legislation is the Patents Act 1992 (as amended) (Patents Act). Patents granted under the Patents Act can be for 20 years (full-term patent) or ten years (short-term patent). To obtain protection on a long-term patent, an invention must:
- Be new or novel.
- Involve an inventive step.
- Be capable of industrial application.
- Not fall within any excluded categories (for example, a mathematical method or scientific theory).
The criteria for a short-term patent are similar. The key difference is that, for a short-term patent, there is a lower standard of inventiveness required and the applicant does not need to provide evidence of novelty in respect of the invention.
To fulfil the criteria of novelty and inventiveness for a full term patent, the invention must not form part of the state of the art (which includes anything made available to the public before the date of filing of the patent application).
Scope of protection
The following, among others, are not patentable inventions (Patents Act):
- A method for treatment of the human or animal body by surgery or therapy.
- A diagnostic method practised on the human or animal body.
However, a product, substance or composition used in any such method can be patented (such as medicines and surgical instruments).
Biotechnological inventions that are capable of protection must also fulfil the requirements for patentability set out in the Patents Act (see above, Conditions and legislation). Biotechnological inventions are patentable if they concern any of the following, among others (European Communities (Legal Protection of Biotechnological Inventions) Regulations, 2000 (S.I. No. 247 of 2000):
- Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature.
- Plants or animals, if the technical feasibility of the invention is not confined to a particular plant or animal variety.
- A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.
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This article first appeared in the Practical Law Multi-Jurisdictional Guide 2014/15 Life Sciences: Pharmaceutical IP and Competition Law in Ireland and is reproduced with the kind permission of the publisher Practical Law Company.
For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, visit Medicinal product regulation and product liability in Ireland: overview.