Table 4.

How to justify the novelty and the inventive step of an oligonucleotide with regard to prior art.

Is the Target Known?	Is There at Least One Oligonucleotide against This Target?	Novelty?		Inventive Step?
No	No	Europe	Yes, because the target is new (functional definition possible; however, in the US the oligonucleotide must have a modification to be eligible).	Europe	Yes, because the target is new.
		United States		United States	Yes, but the USPTO could refuse a patent on the target (comparison to the decision between Amgen v. Sanofi [61] relating to the protection of antibodies).
Yes	No	Europe	Yes, because it is the first oligonucleotide used in therapy (however, in the US, the oligonucleotide must have a modification to be eligible and a functional definition is not possible).	Europe	Yes, if the oligonucleotide has a particular functional characteristic.
		United States		United States
Yes	Yes	Europe	Yes, if the oligonucleotide has a different sequence/structure (e.g., with modifications) than oligonucleotides of the prior art (However, in the US, the oligonucleotide must have a modification to be eligible and a functional definition is not possible).	Europe	No, unless the oligonucleotide has an unexpected or new property compared to the oligonucleotides disclosed in the prior art (e.g., addition of a new modification, surprising effect) or if the oligonucleotide targets a particular region (e.g., a particular region of a gene).
		United States		United States