The USPTO has issued new guidelines for Examiners to clarify what constitutes patent eligible subject matter for claims involving laws of nature. This has been prompted by the 2013 Myriad decision, which determined that genomic gene sequences (BRCA2) were not patent eligible. As explained below, the USPTO have now clarified how this decision may be applied to other product and method claims which concern naturally occurring subject matter.
The USPTO have established a three step test to determine whether a claim is patent eligible. The first question that will be applied to a claim is whether the claimed subject matter is directed to one of the four statutory categories (a process, machine, manufacture or composition of matter). If the answer to this question is yes, then question 2 is applied. (If the answer is no, then the claim is not patentable). Question 2 asks whether the claim recites or involves a judicial exception (including an abstract idea, laws of nature/natural principles, natural phenomena and natural products). If the answer to this question is yes, then question 3 is applied. (If the answer is no, then the claim is patent eligible). Question 3 queries whether the claim as a whole recites something significantly different than the judicial exception. If the answer is yes, then the claim is patent eligible.
Thus, in order for a claim which concerns a naturally occurring product/principle to be patentable in the US, it must either encompass a product which is markedly different to that which occurs in nature or the claim should include steps which apply the excluded natural product/phenomena in a significant way.
Hence, it may not be possible to patent any naturally occurring products in the US, which have not been modified in some way or which are not part of a specific method/process. Claims directed to proteins, chemicals, nucleic acids etc, which are found in nature, are not patent eligible even if those products have been isolated and characterised. A modification must be made to claim the product per se, e.g. a cDNA sequence maybe allowable.
This therefore greatly limits the scope for patent protection in the US for biotech inventions.