Monday, 15 December 2014

Types of Pharmaceutical Patent - Product, Process, Formulation and Method

Types of Pharmaceutical Patent - Product, Process, Formulation and Method

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. 
There are several types of patent or patent claim that are particularly relevant to pharmaceuticals. These are:

Product patent or claim

This claims the active chemical substance as a new chemical entity and is generally regarded as being superior claim. If there is a product claim on the drug then none but the patent holder or licensee can make, sell or import the chemical for any use without infringing the product patent.
This type of patent claim is now allowed in most commercially important countries, although it is a fairly recent event in many others. For instance, Japan, Switzerland, Sweden and Italy introduced product patent for pharmaceuticals in the 1970’s, Austria in 1987, Portugal, Spain and Greece in 1992.
The novel drug is claimed either by chemical name or by chemical structure, or both. The drug may be claimed within a Markush structure. This comprises a core chemical structure with several optional chemical groups that may be attached to the core structure. This is known as a generic claim to a compound. A drug will be covered by the generic claim and there may be a specific claim to the chemical as well. Some Markush structures are so general that they can cover millions of actual chemicals.
Note that in patentees the term ‘composition of matter’ actually denotes a product claim.

Product by process patent or claim

This type of claim ‘claims’ a chemical or other process used to manufacture the drug whenever the drug is made by the patented process. It is the ‘next best’ type of claim as it also confers protection against importation of a product. However, the drug can be made and sold if another company can devise a commercially viable process not covered in the patent.

Process patent

This claims the chemical or other process used to manufacture the drug. The chemical product itself is not covered. Because of the difficulty of proving that another company is using the patented process, many countries have a ‘burden of proof reversal’ clause where the potential infringer has to prove that the patented process is not being used. In the USA, the patent law was amended to made importation of the product of a patented process an infringing act, although this is not generally the case.

Formulation patent

This claims the pharmaceutical dosage form on the drug, commonly also known as a composition but not to be confused with ‘composition of matter’ (see previously). It may take the form of a formulation of a particular drug or class of drugs, or a general formulation applicable to many drugs with different actions, such as slow release technologies, transdermal patches, etc. There may also be formulation process patents covering the manufacturing processes used to make the formulation.

Method of use

This covers the use of the drug to treat a disease. This type of claim is originally allowed in the USA and Germany, but is now being accepted in other countries including the UK. However, a careful wording of the claim in European patent application allows this type of claim. The European claim usually goes ‘... use of drug x to manufacture a pharmaceutical dosage form to treat ...’, thereby avoiding a direct method of treatment claim.
Remember that not all types of claim are allowed in all countries and some countries do not have patent laws.


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