To be patentable any new product or process must demonstrate the following:
- Novelty: it must be novel over any “prior art” (see definition below) and not disclosed prior to filing
- Non-obviousness: there must be a clear “inventive step”- something not obvious to a person “skilled in the field” (see definition below)
- Utility: it must be capable of some use or application that provides benefit to a user
- Sufficiency: the description of the patent application as filed must be sufficiently detailed so as to allow a person of ordinary skill in the field perform the invention.
“Prior Art”: all information in the public domain before date of filing.
“Skilled in the field”: often considered to be a Post-doctoral Scientist in general field.
As patents are national rights, it is ultimately the National Governments who decide what is patentable. Therefore, national law determines what is patentable in any given country. In most countries in the world, the right to a patent belongs to the party who first files their patent application. In contrast, in the US, the right to a patent belongs to the person who invented first. Thus, the US operates a “first to invent” system. Where two or more parties have patents/applications that claim the same invention, the US Patent Office may declare an Interference Proceedings to determine which party owns the invention.
The following subject matter is not patentable in Europe:
- Human beings
- Human cloning processes
- Human germ line therapy
- The use of human embryos for commercial purposes
- Transgenic animals, where suffering to the animal outweighs benefit to mankind
Patents may currently be obtained in Europe for the following:
- Nature-identical and altered biological products (genes, proteins, peptides, cell lines)
- New uses of nature-identical and altered biological products
- Devices and machines
- New uses of known devices or machines
- Diagnostic/Prognostic/Theranostic methods and products