DNA and proteins are treated by the Patent Offices as chemical entities.

If they are claimed in isolated or purified form, then that form will be novel over the forms that are present in the organism from which they are obtained.

Patents may also be granted for artificial DNA constructs such as cDNA and genetically engineered proteins. The patent application must give details of the use of the new gene or protein.

Sequence Listings

If the patent application mentions DNA/RNA sequences of 10 or more nucleotides or polypeptide sequences of 4 or more amino acids (whether or not such sequences are claimed in the claims section), then the patent application must be accompanied by a “Sequence Listing”, which lists the sequences in a defined format and gives them Sequence Identifier Numbers (SEQ ID NOs).

The Sequence Listing must be filed in electronic format so that the Patent Offices can readily compare the sequences in the Sequence Listing against those in its databases.

If such sequences are referred to in the patent claims, then the SEQ ID NOs should be used (instead of reciting the full sequences in the claims).

Examples of claims to DNA sequences include the following:

1. An isolated nucleic acid molecule having a sequence identity of at least 90% with SEQ ID NO: 1 and which encodes a melanocortin receptor.

2. An isolated nucleic acid molecule which codes for a polypeptide of SEQ ID NO: 2. Claim 1 above covers not only a DNA or RNA sequence of SEQ ID NO: 1, but also variants of that sequence which encode the specified receptor. (It is necessary to include a functional definition of the nucleic acid molecule (e.g. “which encodes a melanocortin receptor”) in order to exclude molecules which are non-functional.)

Polypeptide and peptide sequences

Examples of claims to polypeptide and peptide sequences include the following:

3. A purified polypeptide comprising an amino acid sequence having at least 95% sequence identity with SEQ ID NO: 2 and which binds FSH with a Ki of less than 10 nM.

4. A peptide of formula X1-X2-A-G-C-X3-L-V-F-X4, wherein X1 is acetyl or is absent; X2 is L or I; X3 is F or W; and X4 is amide or is absent.

If the invention is based on the identification of a new gene or polypeptide, then patent claims to vectors or plasmids comprising the claimed genes and host cells comprising such vectors/plasmids will generally be allowed in the same patent application.

In 2013, the US Supreme Court ruled that US patents could not be granted for genomic DNA because such genomic DNA was considered to be a “product of nature”. Since that time, the USPTO has extended this principle to reject patent applications on any product of nature (e.g. a new drug isolated from a plant).

It is important to note that this ruling only applies to US patents; it does not affect the patentability of genomic sequences or other natural products in other countries. Furthermore, the ruling does not affect the patentability of artificial DNA constructs (such as cDNA or of expression vectors comprising genomic DNA), or of patent claims to methods of using genomic DNA.