In the event of a pandemic, the NHS could be put under considerable strain. A crucial step to managing and helping this situation is the development of tests that will allow healthcare workers to determine whether they have the illness, thus informing whether they can return to work or whether they need to stay at home to rest and recover.

 

A key aspect of this work will be the development of a greater base of UK diagnostics companies. This article aims to provide companies with information relating to the IP provisions in this area so that they can determine what may or may not be patentable.

 

In order for an invention to be patented in Europe, it is necessary that it is new, inventive and capable of industrial application. In addition, there are certain exclusions applied by some patent offices to prevent patents being granted relating to certain technologies.

 

In Europe, the patentability of medical related inventions is based on the principle that practitioners should not be prevented or restricted at the point of care of a patient by the concern that a treatment or diagnostic method may be protected by a patent. The above principle has led to 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.”

 

Thus, in some cases, it may be difficult to obtain protection for a diagnostic method in Europe. However, despite the above exclusion, diagnostic methods are patentable in Europe under certain circumstances as set out below:

 

Where the method is carried out separately from the human or animal body

 

As mentioned above, under European Patent Law there is a provision that diagnostic methods that are practiced on the human or animal body are not patentable. However, if the technical steps of the claimed diagnostic method can be carried out separately from the body the method may be considered to be patentable. For example, a diagnostic method that is carried out on an in vitro tissue sample would not be carried out on the human or animal body and as such, may be patentable. However, the treatment of a blood sample by dialysis, where the blood is subsequently returned to the patient would be excluded from patentability since the patient would have to be present. When drafting a patent application we recommend including at least one in vitro step in the claims and omitting any non-essential steps that are practised on the human body. For example, where a claim relates to a method of diagnosis based on identifying a particular property of a sample extracted from a patient, the step of obtaining the sample from the patient should be omitted from the claims and the claims could instead refer to carrying out the method on a sample obtained from a subject.

 

Where the method does not include all steps mentioned in EPO Decision G1/04

 

The EPO Enlarged Board of Appeal in its decision of G1/04 sets out the conditions that must be met for a method to relate to a diagnostic method. In this decision, it was found that a claim must include method steps relating to all of the following phases to be excluded from patentability:

 

(i) the examination phase, involving the collection of data,
(ii) the comparison of these data with standard values,
(iii) the finding of any significant deviation, i.e. a symptom, during the comparison,
(iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis for curative purposes stricto sensu).

 

Thus, to be excluded from patentability, a diagnostic method must include all of the necessary steps to obtain and analyse data, and come to a diagnostic conclusion. If any one of these steps is missing, the method will not be regarded as a diagnostic method within the context of Article 53(c) EPC. However, it would not be possible to overcome a potential exclusion by deleting one of these steps if all of these steps would be understood to be essential to the method. Therefore, when preparing a patent application, if possible we suggest including a description of how one or more of these steps is not essential to the method.

 

For more information on the EPO Boards of Appeal decision of G1/04 (Diagnostic methods), please click here: EPO Decision G 0001/04 (Diagnostic methods) of 16.12.2005 

 

Methods that do not lead to the diagnosis of a clinical condition

 

Methods that do not lead to the diagnosis of a clinical condition (e.g. prognostic methods) are not excluded from patentability. For example, a method of collecting data during an examination phase (i.e. based on step (i) above) would be considered patentable. In addition, methods based on step (iv) above, e.g. a method of data collection or analysis that does not enable a decision to be made on the treatment required will also be patentable.

 

Summary

 

Although diagnostic methods practised on the human or animal body are excluded from patent protection at the EPO, this does not prevent the patenting of diagnostic methods under certain circumstances. By identifying the central aspects of an invention and using careful wording when drafting a patent application, it is often possible to obtain patent protection for many aspects of medical related inventions.

 

At Maucher Jenkins we have significant experience of helping medical and scientific companies get the best IP protection for their research and development in the area of diagnostics.

 

For more information on our work in medtech and medical devices, please click here: Medtech and Medical Devices