But DNA and genes occur naturally, so how can they be patentable?
DNA is existent in all living matter. For instance, in man, the 3 billion bases of DNA (‘genomic DNA) comprise our genes. Over 90% of this genomic sequence is believed to be 'junk'. The junk sequences are interspersed amongst 50,000 to 100,000 individual genes which determine our genetic make-up and, in many cases, predisposition to disease. Only genes which are isolated from this tangle of genomic DNA are, in patent law, novel and thus patentable. Article 5.2 of the directive deals with this point. A patent claim to an isolated DNA sequence does never 'read on' to genes as they exist in nature.
Furthermore, the DNA in patent claims is frequently claimed as cDNA (complementary DNA). cDNA is a copy of the genomic DNA without the interspersed junk sequences (‘introns’). cDNA does not occur naturally (except in rare cases where a gene is not interrupted by introns) and is novel for that reason alone.
Raw sequence data is NOT patentable (see Directive 5.1). However, identification of genes associated with disease is far from simple. Identifying a gene (isolated from the body!) and establishing a use or ‘industrial application’ for it elevates the exercise to one of invention (patentable) and not one of discovery (unpatentable). The industrial application has to be included in the patent specification (Directive 5.3). Patent office examination procedures are in place to check that only what is patentable is in fact patented and examination standards are being increasingly tightened up.
Patenting natural products has been common practice in the US and Europe for many years. Provided the compound is novel, in the sense of having no previously recognised existence, then it can be claimed (see above) - provided all the other usual criteria for patentability (e.g. inventive step, utility) are established. Examples of natural products patented in the past include daunorubicin used in the treatment of tumours, streptokinase used in myocardial infarction and cyclosporin used to prevent tissue rejection in organ transplant surgery, to name but a few.
Furthermore, the DNA in patent claims is frequently claimed as cDNA (complementary DNA). cDNA is a copy of the genomic DNA without the interspersed junk sequences (‘introns’). cDNA does not occur naturally (except in rare cases where a gene is not interrupted by introns) and is novel for that reason alone.
Raw sequence data is NOT patentable (see Directive 5.1). However, identification of genes associated with disease is far from simple. Identifying a gene (isolated from the body!) and establishing a use or ‘industrial application’ for it elevates the exercise to one of invention (patentable) and not one of discovery (unpatentable). The industrial application has to be included in the patent specification (Directive 5.3). Patent office examination procedures are in place to check that only what is patentable is in fact patented and examination standards are being increasingly tightened up.
Patenting natural products has been common practice in the US and Europe for many years. Provided the compound is novel, in the sense of having no previously recognised existence, then it can be claimed (see above) - provided all the other usual criteria for patentability (e.g. inventive step, utility) are established. Examples of natural products patented in the past include daunorubicin used in the treatment of tumours, streptokinase used in myocardial infarction and cyclosporin used to prevent tissue rejection in organ transplant surgery, to name but a few.
