In both the EU and the US native gene and protein sequences cannot be patented. However, under both regimes biological materials, and gene/protein sequences identical to those found in nature, may be patent protected in certain circumstances.
The requirements for patentability of gene/protein sequences differ between the EU and US, leading to a number of issues and considerations that patentees and patent drafters must be aware of when seeking to protect biological material in these territories.
Europe
European Union directive 98/44/EC (the Biotech Directive) and the EPO's Guidelines for Examination govern the patenting of biological material in countries under the jurisdiction of the EPO.
The Biotech Directive defines "biological material" as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. It covers nucleotide sequences, full length genes, complementary DNA (cDNA), and fragments.
Under the Biotech Directive, inventions which are new, involve an inventive step and are susceptible of industrial application are patentable, even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
Additionally, biological material that is isolated from its natural environment or produced by means of a technical process may be the subject of an invention, even if it previously occurred in nature.
For biological material from the human body, the provisions are slightly different. The simple discovery of the sequence or partial sequence of a gene cannot constitute a patentable invention. Only if any of the following are satisfied can naturally occurring genetic sequences from the human body be patentable:
- biological material isolated or purified from its natural environment
- biological material produced by means of a technical process (eg to identify, purify or classify it, which human beings alone are capable of putting into practice and which nature is incapable of accomplishing, even if it previously occurred in nature) (eg artificial DNA constructs, cDNA, genetically engineered proteins)
- discovered to exist in nature and a technical effect is revealed (eg gene used in making a certain polypeptide or in gene therapy).
Additionally, to meet the requirements of patent eligibility, the use and industrial application of a genetic sequence or encoded protein must be disclosed in the application as filed. For example, merely identifying the structure of a protein, which does not have a clear role or practical use, is not enough.
Under the EPO regime, the novelty of biological material has been held not to be destroyed by a naturally occurring sequence:
- the prior publication of a sequence of the human genome does not harm the novelty of the sequence claimed in an isolated state
- prior disclosure of the isolated sequence does not anticipate the corresponding cDNA that does not occur in nature
- prior disclosure of the cDNA does not anticipate short sequences of special interest.
US
In the United States, the patentability of biological materials and genetic sequences is markedly different to the EU regime. Until 2013 natural biological substances could be patented if they were sufficiently "isolated" from their naturally occurring states. However, the Myriad case , which involved patents claiming the sequences of two human genes (BRCA1 and 2), changed the legal position surrounding patenting of biological substances.
Myriad decided that genes that had simply been isolated from the genetic material of an organism (whether human or other) could no longer be patented. This decision was reached on the basis that DNA is a "product of nature", and because nothing new and useful is created when a gene is located/discovered or simply isolated there is no intellectual property to protect.
The exclusive right to isolate an individual's genes and create cDNA was held to not be allowed. This decision had substantial consequences, and invalidated over 4,300 patented human genes.
Comparison
Although the Myriad decision seems to mark a substantial difference in the US to the position under EU law, where isolated genetic sequences can be patented, the regimes are not as dissimilar as it may be first thought.
In the both the US and at the EPO, artificial DNA constructs or sequences altered by humans remain patentable, as they are not naturally found in nature. cDNA is also patentable, because it is synthetically produced from the mRNA molecule and is not a naturally occurring product of nature.
Additionally, method claims are not implicated by the US Myriad decision, so an innovative method of manipulating genes may be patentable, as may new applications of knowledge regarding newly discovered gene sequences, or modified gene sequences in both the US and EU.
Considerations
The differences between the US and EPO regimes regarding isolated gene and protein sequences must be considered by patentees and patent drafters when formulating a patent strategy or applying for patent protection. Most importantly, isolated biological material can be protected in the EU, but similar subject matter will not be patentable in the US.
This may cause contrasting levels of patent protection across the EU and US between isolated sequences and synthetically produced sequences from the isolated biological material, which could have substantial impacts on the commerciality of a new invention, and how patent portfolios are dealt with in the different jurisdictions.
