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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


<< Patent Intelligence Briefings / Supplementary Protection Certificates >>

Pharmaceutical Patents

Patents protecting the intellectual property of products in the industrial area are vital to the owners existence. This is particularly so for the research-based pharmaceutical industry. Thus the enormous costs that are invested in terms of time and money for research and development, will be protected by secure patents. It is estimated that the costs of developing a new chemical entity (NCE) can be as much as £800millions and rising. The fact that the industry has been successful in recent times has meant that it is running out of new areas to cover. Also finding drugs that show significant improvements over those already existing is becoming increasingly difficult and costly.

In the UK, the NHS is the major customer, though the National Institute for Clinical Excellence (NICE), try to ensure that new drugs have significant benefits before allowing NHS prescriptions to be issued. Once the drug is patented there are 20 years of exclusivity. However, before any drugs can be marketed there are extensive procedures covering testing and licensing prior to their use. In effect, on average, half the allotted time span is exhausted, but this has been, to some extent, rectified by pharmaceutical patent term extensions. Even with these shortcomings, the industry has been very profitable. Most of the big companies have much of their turnover tied up in very few products. So, with diminishing patent time other producers have entered the field without the encumbrance of large research and development costs.

Nevertheless, to continue to feed the growth of new products, their protective patents are a necessity. Without them innovation will disappear. By the same token, patents allow the originators to make a reasonable return on investment, but not to excess. It is the term ‘reasonable’ that is often called into question. When the exclusivity period has ended producers must be allowed to supply products at more reasonable costs. Therefore, it is essential that knowledge about patents and their expiries are known by both originators and those who may wish to produce those products in the post-patent period.

Patents can seem confusing to read and understand and have a particular language of their own. For instance, ‘prior art’ refers to the technical background information relating to the invention and ‘one skilled in the art’ is a person competent in the technology the invention covers. OPI stands for open to public inspection, ie the document is available for the general public to read.

Patents are national or regional. They have no force outside the territory where they are granted. It must also be remembered that some countries do not have patent laws and certain types of invention, such as pharmaceuticals, can be excluded from patent cover. Countries are constantly changing their patent laws and the trend is to a more uniform system. Where new laws are coming into force, they tend to be in line with the patent laws of the western industrialised nations. International agreements such as the General Agreement on Tariffs and Trade (GATT) can have a profound effect on patent laws, and more recently Trade Related Aspects of Intellectual Property Rights (TRIPS). The strength of any granted patent depends on many factors including the way patent laws are interpreted in a country; the same patent laws can and are interpreted quite differently in various countries.

Without knowledge of the basic principles, it is impossible to grasp and understand the more complex patent scenarios. Once lawyers become involved, the simplest concepts can suddenly seem extremely complex. It must be remembered that patents can be a ‘double-edged sword’. This price of obtaining exclusivity and a monopoly on your invention for a fixed period is disclosure. So, to quality for this state monopoly you have to disclose to the whole world exactly what you have done. Some may consider this too big a price to pay.

The MPA patents database covers the patent expiry of all EU marketing authorised pharmaceutical products. It includes SPCs, paediatric extensions, EU first marketing authorisation and more...

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