In decision T 0264/17, a Board of Appeal of the European Patent Office recently decided that pharmacologically, metabolically or immunologically inactive substances – i.e., substances which do not show any chemical interaction with proteins of the body – can be patentable under Article 54(5) EPC for a novel medical use.
EP 12 795 927, on which the decision is based, is directed to a known synthetic lubricant consisting of a known perfluoroether for use as a replacement for the synovial fluid in diseased joints of animals and humans.
The Examining Division had rejected the application on the grounds of lack of novelty, since the terms “substances or composition” in Article 54(5) EPC did allegedly only apply to “active” substances. The effect of the lubricant in the joint was, however, purely physical.
The Board noted that, according to G 5/83, it is necessary to evaluate carefully by which means a therapeutic effect is achieved.
The Board found that the therapeutic effect of the lubricants was not purely physical but rather based on the omniphobic, i.e., simultaneously hydrophilic and hydrophobic – chemical – properties of the ethers, which resulted in the desired low interaction with the body tissue. Therefore, the lubricants had to be regarded to as active substances for medical use and Article 54(5) EPC was found applicable to these substances albeit they are not classical medicinal products with a pharmacological, metabolic, or immunological effect.
In view of earlier decisions T 1758/15 and T 2136/15, in which claims directed to medical uses of injectable filling materials whose compositions were found irrelevant to the effect were rejected because they acted solely through their three-dimensional structure, the Board clarified that claims directed to medical uses are, under certain circumstances, also applicable to substances which are not medicinal substances in the classical sense.
As a consequence of this decision, therefore, whenever claims directed to a medical use of a substance are desired, the therapeutic effect should be connected in the application to chemical properties of the substance.