Can a protein or nucleotide sequence ever be the subject of a patent? The answer is not a simple one and depends on both how the claims are drafted as well as the jurisdiction in which the patent is filed.
Australia does not specifically exclude proteins or nucleotide sequences from patentability. As with every application, the invention as defined by the claims needs to meet the overall requirements of patentability. The first hurdle is to prove that the invention meets the manner of manufacture requirement.
For the substance to have been “made” by the inventor, there needs to be a change in the state of the product. The two main issues in Australia when reviewing whether a nucleotide sequence or polypeptide sequence is patentable are:
- to establish the substance of the claim (regardless of how it is drafted); and
- to evaluate whether the substance of the claim is actually made.
Nucleotide sequences and Genetic Material
In Australia, nucleotide sequences that are identical to sequences found in nature are not patentable subject matter. This was established by the High Court in D’Arcy v Myriad which held that the act of simply isolating a sequence of nucleic acids was not sufficient to be patentable material. The rationale was that there was no manner of manufacture defined in the claims which identify a nucleotide sequence if the same sequence is found in a living organism. The mere act of isolating, identifying, and purifying the nucleotides does not change the sequence of the genes and so the invention is not a manner of manufacture.
The High Court also stated that the same principles would apply to complementary DNA (cDNA), i.e., DNA that corresponds to the mRNA sequence of a gene, where the cDNA replicated the naturally occurring DNA.
It follows that it is possible to seek patent protection for synthetic DNA where the DNA sequence cannot be found in a living organism. It is also possible for patent protection to be obtained for methods used to identify a gene or nucleotide sequence.
In the US, the courts have taken a different approach. Although an isolated gene sequence is not patentable subject matter, cDNA can be patentable subject matter.
A broader approach is taken by the European Union under the European Union Directive 98/44/EC. Although native gene sequences are also not considered to be patentable, isolated genes and peptide sequences are patentable subject matter (even if they are identical to those occurring in a living organism), provided that the claim discloses an industrial application.
Proteins and polypeptides
Following the High Court decision in D’Arcy, IP Australia has indicated that sequences coding for naturally occurring peptides would not be considered to be patentable subject matter. On the other hand, sequences would be potentially patentable if the claims were directed to isolated, modified, or synthetically derived peptides (including claims to antibodies).
Currently, the following is listed on the IP Australia website as being acceptable patentable subject matter:
- synthetic DNA or nucleic acid sequences only where the genetic information does not exist in the DNA blueprint or genome of any human or other organism
- an isolated protein expressed by a gene
- vectors (such as plasmids or bacteriophage vectors or viruses) containing a transgene
- methods of transformation using a gene
- host cells carrying a transgene
- higher plants or animals carrying a transgene
- organisms for expression of a protein from a transgene
- general recombinant DNA methods such as PCR and expression systems.
Claims to isolated or modified polypeptides can be described by an amino acid sequence or its functionality. Antibodies can be patented, and the claims are usually drafted to be limited to the specificity of antibodies to the complementary determining region.
Once the subject of the claims has successfully passed the manner of manufacture requirements, the invention as defined by the claims still needs to be sufficiently enabled i.e. such that a skilled person can replicate the invention over the scope of the claim, and be useful.
Stay tuned for our next blog posts on recent decisions from the APO in relation to the drafting of claims in relation to polypeptides and nucleotides and the factors influencing whether the invention is sufficiently disclosed and enabled.