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Patent Intelligence Briefings

Pharmaceutical Patents

Supplementary Protection Certificates (SPCs)

Paediatric Extensions

Data & Marketing Exclusivity

Exclusivity vs. Patent Cover

Paediatric Use Marketing Authorisations

The Specific Mechanism

Patents, Trademarks, Copyrights

Product, Process & Formulation Patents

Key Patent Definitions



Singulair - Sigma Pharmaceuticals Plc vs Merck Sharpe & Dohme

Specific Mechanism – Ambiguity, Confusion and Conflict

Medeva and Georgetown - Combination Drugs and SPCs


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Patents, Trademarks and Copyright

What is intellectual property?

Intellectual property, also sometimes referred to as industrial property, normally covers patents, trademarks, copyright and industrial designs.


A patent is a temporary monopoly granted by the State and given by law to an inventor; this automatically prevents others from exploiting the invention. This is an important point to remember; the patent does not give the inventor the right to exploit the invention – an inventor can have this right without a patent but without one, others can copy the invention. The term of the monopoly varies from country to country but usually ranges from 15 to 20 years, with the international trend towards a 20-year term.

In return for the patent, the inventor must make a full disclosure of the invention to the public. This is usually carried out via a printed patent specification which gives the background to the invention and states the inventor’s claims. The claims define the legal scope of what is being protected by the patent. A patent may have several claims in which case these are set out as broadly as possible, while later claims become more and more specific. The claims must reflect the subject matter described in the text of a patent – they must be ‘fairly based’ on the text. The wording of the claims can be critical to the strength of any resulting patent. For instance, if an invention is claimed comprising certain features, then other features, even if not described in the patent, may be present. However, if the invention is described as consisting of certain features then no other features may be present – the patent rights are said to be ‘exhausted’.


Trademarks are names, designs, etc, which identify a product as belonging to a specific company. They may be registered or in some countries there may be a common law right to a well known trade name. Often trademarks can be renewed indefinitely. The oldest registered trademark in the UK is the brewers’ Bass’ red triangle – this is Number 1 on the Trademark Registry. Trademarks are extremely important to the pharmaceutical industry, particularly where laws state that a pharmacist must dispense the brand specified on a prescription, even if a cheaper generic version is available. It is therefore vital to get prescribing doctors to show brand loyalty and may be a clue to some recent almost unpronounceable generic names favoured by pharmaceutical companies’ compared to the memorable and easily spelled trade names.


Copyright is usually more applicable to literary or artistic works and gives the author/artist the rights to prevent copying of an item without permission. In the UK this right lasts for 50 years after the author or artist has died. However, copyright also applies to technical articles, packaging, information to consumers, etc, and so may be of use to pharmaceutical companies.

Industrial designs or utility models cover the functional shape of an article and may be applied to tablet shapes, medical devices such as inhalers, etc, in the pharmaceutical field. Again they last for a limited period but while in force prevent copying of the particular shape of the product.


Know-how is the acquired knowledge and expertise built up within a company or institution. It is difficult to copy but may be independently achieved and can exit the company via the personnel who possess it.

Other Common Terms

Other terms which may be found include Certificates of Invention. These acknowledge the inventor as the true inventor of an invention but confer no practical rights on protecting the product. These were the only form of intellectual property available for pharmaceuticals in some countries including many of those in the former Eastern Bloc. Petty patents are available in some countries giving limited rights to inventions of low novelty, and plant patents or special plant breeders’ rights can be obtained to cover new plant varieties.

These intellectual property rights are treated as property – they may be sold outright to another party or they may be rented for a time to someone else, ie licensed to someone for a set period of time for agreed fees known as royalties. This form of licensing should not be confused with the Product Licence sought by a company as authority to market a drug.


In general, for an invention to be patentable it must meet certain criteria. These are:

It must be novel. This is a practice increasingly acknowledged worldwide or known as absolute novelty, ie the invention must not have been made available to the public anywhere in the world. Some countries still have local novelty requirements ie the invention must not have been disclosed in that country, but as most commercially important countries require absolute novelty it is best not to jeopardise a potential patent by an indiscreet disclosure of an invention.

It must not be obvious or it should be ‘inventive’. This means that the person ‘skilled in the art’ would not automatically think of the invention as the next logical step to what has gone before. This is often a difficult concept as many inventions may seem obvious once they have been invented, but the counter argument is if it was so obvious why didn’t someone do it before! Obviousness is frequently used to challenge a patent.

It should be capable of industrial application. This usually means that if it can be made and sold it meets this criterion. The term ‘industrial’ is interpreted here in a very wide sense.

The degree to which these criteria are applied to patent applications differs from country to country.

Many things are also considered to be unpatentable. These include scientific theories and discoveries; ideas; computer programs; natural products, a great problem for the biotechnology industry but not insurmountable — as they can be claimed in their purified forms; methods of surgical treatment of human or animal bodies; inventions likely to cause or incite illegal or immoral behaviour. In many countries it appears that pharmaceuticals are or were unpatentable.

A patent should cover aspects of a single invention only; this is known as unity of invention and again is enforced by different degrees in various countries.

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