Chemistry and the Skilled Person

Almost undoubtedly, those with an interest in the patent field will have heard patent attorneys and examiners alike talk about “the skilled person”.  This fictitious person represents a standard against which numerous aspects of patentability are assessed.  But who is this “skilled person”? What capabilities and expertise do they have, and what considerations need to be kept in mind within the chemical field during drafting and prosecution of European patent applications, or the formulation of an Intellectual Property (IP) strategy in Europe?

1. A skilled person: has no inventive capability

This may come as a surprise to some, but the skilled person is incapable of innovation.  The skilled person is considered to be an experienced practitioner, well-informed in the relevant technical field, and aware of all relevant published materials.  Crucially however, they have no inventive capacity – under the European Patent Convention (EPC) they are capable of “routine” experimentation only.  This is often in stark contrast to the capabilities of members of a business’s R&D department, whose inventive capabilities will be far greater.  This contrast brings to light an important point to be borne in mind for a company’s approach to IP.

Under the EPC, inventiveness is assessed through the eyes of the skilled person (not through the eyes of an inventor).  In view of this, care must be taken when assessing the patentability of any identified technical developments within a company.  In the mind of an innovative individual working within R&D, a new modification to an existing chemical process/product might seem like an obvious next step, but such steps might indeed be deemed inventive under European practice.  For example, if a skilled person is only capable of routine experimentation, is it really obvious to them to manipulate the conditions of a reaction in a particular way, or to introduce that particular additional component? The risk of considering such developments purely through the eyes of an inventor might mean that patentable inventions are overlooked and the opportunity to obtain protection for commercially advantageous subject-matter is lost.

Therefore, crucial to the development of a strong intellectual property strategy is the placing of importance on, and encouragement of, open discussion within a business in relation to any technical advancement to avoid missing the opportunity to realise the commercial gains from protecting commercially relevant subject-matter.

2. A skilled person: needs instruction

A patent application must contain enough information for the skilled person to work the invention.  In Europe, this standard is called “sufficiency of disclosure”.  This requirement extends across the whole scope of the patent.  When drafting a European patent application, care must therefore be taken to provide the skilled person with sufficient detail to enable them to carry out the invention across its broadest form.

Within chemistry, such detail will vary from invention to invention, but typically extends to reaction conditions, measurement methods, and the specific nature of chemical reagents.  Ultimately, enough detail for someone lacking inventive capability (i.e.  the skilled person) to read the patent, go away, and repeat the working of the invention.

3. A skilled person: needs evidence

The standard mentioned above of “sufficiency of disclosure” has particular implications on data requirements for chemical patents.  Simply, the patent must provide enough information for the skilled person to work the invention in its broadest form.

For innovations in the fields of chemistry and life sciences in particular, there is more often than not a need for broad supporting experimental data to persuade a European examiner that the standard for sufficiency of disclosure has been met, i.e.  the skilled person can work the invention, across the entire claim scope.

The requirement of appropriate supporting data must be a key consideration in any IP strategy.  Generating additional experimental evidence to back up an initial proof of concept finding might take time, but care should be taken to weigh up the advantages of filing a patent early versus the potential risks associated with filing without sufficient data.

The above are just a small number of examples as to why it is worthwhile to consider IP strategy at an early stage, to ensure that commercially relevant inventions are captured, and protected.