Patentability Of Methods Of Treatment And Diagnosis

Author:Mr Reuben Friend
Profession:Venner Shipley LLP

The European Patent Office's (EPO's) approach to the patentability of inventions in the medical field is based on the principle that medical practitioners should not be restricted at the point of care of a patient by the concern that a treatment or diagnostic method might be covered by a patent.

This has led to the provision of Article 53(c) of the European Patent Convention (EPC), which specifies that:

"European patents shall not be granted in respect of ... methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body..."

It may appear that Article 53(c) EPC significantly prohibits the patenting of inventions in the medical field in Europe. However, as discussed below, with careful wording, it is still possible to validly patent many inventions in the medical field.

Method of Treatment

Whilst methods of treatment are not patentable in Europe, it is possible to validly patent the use of a substance or composition for surgery, therapy or diagnosis under the provision of Article 53(c) EPC second clause, which states that:

"...this provision shall not apply to products, in particular substances or compositions, for use of these methods."

This enables the use of a purpose-limited use claim to circumvent the exclusion of methods from patentability provided by Article 53(c) EPC.

If the substance or composition is known per se, but has not previously been used in a medical method, it is still possible to obtain broad protection for the use in any medical method using a so-called "first medical use" claim of the format "[Substance/composition] X for use in [therapy/in vivo diagnosis/surgery]" (Article 54(4) EPC), even if only one therapeutic use has been described in the patent. Thus, novelty and inventiveness is defined by the use of the substance or composition in a medical method, and not the substance or composition per se.

In addition, even if a medical use for any given substance or composition is already known, it is possible to protect a different medical use of that substance or composition using a claim in the format "[Substance/composition] X for use in [treating/ in vivo diagnosis of] Y]" (Article 54(5) EPC). In such claims, novelty can arise from the new disease that is treated. Of course, the Applicant must then show that treatment of the new disease would not have been obvious in order to demonstrate an inventive step.

A medical use claim can also be directed...

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