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.
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).
Patents to DNA and RNA technology are often granted in the following areas: genomics, genetic engineering, gene delivery, DNA vaccines, RNA vaccines, PCR methods, sequencing methods and nucleic acid manipulations including gene editing such as CRISPR.
In particular, the following are patentable in most countries: gene sequences, antisense oligonucleotides, PCR primers and DNA vectors including viral vectors. The DNA and RNA molecules do not always have to be defined by their specific sequences. If the inventive concept of the invention is not limited to a specific sequence, then broader patent claims (not limited to nucleotide sequences) can often be obtained.
Examples of claims to DNA sequences include the following:
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.)
In this area of technology, patents are often granted in the following fields: proteomics, proteins, polypeptides and peptides, recombinant protein expression systems, synthetic proteins, chimeric proteins, industrial enzymes, blood products, glycobiology, biomaterials, protein purification and peptide therapeutics.
The patenting of antibodies and biosimilars and biobetters are also particularly important. [and insert hyperlinks to the other pages on these]
In patent applications which claim protein sequences, the Patent Offices will generally compare the sequence of the claimed protein against previously-known ones, and then assess whether the claimed sequence is both novel and inventive over the previously-known 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.
