There are four main IP rights: patents, trademarks, designs and copyright. IP protection has significant importance to the life sciences sector, as it offers protection against the copying of integral information, for example databases, software coding, and reports.
By far the most important IP rights in life sciences relate to patents. Trademarks are also important, to differentiate a brand and generate customer loyalty. Copyright acts to protect a wide range of works, from software to reports.
Database rights are also of growing importance as life sciences organisations grow, with protection either through copyright or unregistered database right.
Patents
A patent is an IP right which protects technical innovations. It affords the patent owner protection by excluding others from making, using, or monetising an invention for a certain period of time. In exchange for this right, the applicant has to make full disclosure as to how the patent works.
In England and Wales, the Patents Act 1977 lays down four conditions that a patent application must meet before a patent can be granted. The invention must:
- Be new or novel;
- Involve an inventive step;
- Be capable of industrial application; and
- Not be excluded by the Patents Act.
It is important to remember that public disclosure of an invention will mean that it forms part of the “prior art”, resulting in a lack of novelty. Any disclosure of the invention must therefore be subject to the prior signing of an appropriate non-disclosure agreement.
The three most common grounds for attacking a patent application or patent are lack of novelty, obviousness (that is, there is an advance in the state of the art, but it is an obvious advance lacking any inventive step) and insufficiency.
Of particular concern to pharmaceutical companies, is that the treatment of a human or animal body by surgery or therapy and diagnostic methods practised on the body are excluded from patentability, but the exclusions do not apply to products (including compositions and substances) that are to be used in such methods.
In relation to the issue of novelty, the basic rules have been modified to a degree in the life sciences field. Where biological material is isolated from its natural environment or produced by using a technical process (for example, gene sequencing), it is possible for that to be regarded as an invention and potentially patentable.
Trademarks
Essentially, a trademark is a “badge of origin”, connecting a particular product or service with a specific business. In the field of life sciences, it is also generally regarded as a guarantee of quality.
In the UK, trademarks and service marks can be registered in a range of classes and can be renewed indefinitely. The Bass red triangle trademark, the first one registered in England, is still in existence.
Pharmaceutical product trademarks are subject to greater levels of regulation than trademarks for other products, so as to protect public health and safety.
Copyright IP rights
Copyright is the most flexible of IP rights, probably because it can arise automatically, without any registration requirements (this is not true for the US, which operates a copyright registration system).
The author of a work will be the first owner, except where the work was created in the course of employment (and there is no contrary agreement). This will need to be borne in mind when using contractors or self-employed consultants, because they will own the copyright in what they create, unless the rights are assigned.
Database IP rights
Often overlooked, database rights apply to collections of works, data or materials which are arranged in a systematic or methodical way and are individually accessible by electronic or other means.
For more information on the commercialisation of intellectual property rights in life sciences, please contact the Life Sciences team here, or see our Life Sciences services here.