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Types of Pharmaceutical Patent - Product, Process, Formulation and Method
MPA Business Services' drug patent expiration and status review database covers major product/ preparation patents together with any related supplementary protection certificates (SPCs) and paediatric extensions for all products on the European market, including all 27 EU countries plus Switzerland.
Product / preparation patents are critical in understanding whether generic versions of drugs may be marketed. MPA's patent expiration and status review database addressses the key question of patent expiry quickly, accurately and cost-effectively. Once a drug of interest has been identified, it may then be necessary to conduct further searches on other types of patent. MPA is able to do this cost-effectively on a consultancy basis, where needed.
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.
