I recently learnt that a human being has over 25,000 genes and each person has two copies of genes, one inherited from each parent. I also learnt that viruses have two main types of genes, RNA or DNA and thus the classification of viruses as either DNA or RNA such as the Covid-19 virus which is RNA.
As the world steps up its efforts towards finding an acceptable Covid-19 treatment, Kenya has announced that it will start clinical trials by conducting tests on some trial drugs used in the treatment of other viruses like Ebola. Hopefully these clinical trials will be undertaken in adherence to the applicable law which is mainly to uphold the human rights of such patients.
The rights to life, health, privacy and information for such patients ought to be upheld when conducting such trials. Furthermore, the necessary regulatory approvals for the trials must be sought in Kenya as the subjects are Kenyans. Recruitment of patients for the trials has already began.
Part of the ongoing global research efforts to get a cure for Covid-19 have seen an increase in availability of genomic data. Genomic data is basically the complete set of a living thing’s genes and DNA. It is a very technical and scientific study. However, availability of genomic data is crucial to understanding the virus, the human body and treatment options. DNA sequencing, which is another important component of research in this area, is the in-depth study of an organism’s genetic codes.
All these sciences bring to light an emerging area in biomedical research and that is the interrelationship between legal ethics and intellectual property rights. Supposing a researcher has spent a lot of time and resources studying the genetic composition of Covid-19 and discovers something new in the area that would be crucial in getting a cure, would he or she be entitled to a patent? This is the current legal debate on how far one can go in patenting DNA and DNA sequences. Most experts have held that one cannot claim patent rights over such discoveries and I agree with them.
To be granted patent rights there are three main requirements that must be established. The applicant must show novelty, has taken an inventive step and that the patent is industrially applicable. The argument against the grant of patent rights on DNA sequences is that one cannot claim to have invented a naturally occurring substance such as DNA even if they were the first to discover such DNA.
Human beings cannot claim to have invented organisms that were created and were found to be occurring naturally. In the case of Association of Molecular Pathologists versus Myriad Genetics, the subject matter under dispute were the two genes BRCA1 and BRCA2. After a lot of litigation, the Supreme Court in America found that unmodified genes were products of nature and not patentable.
While the decision isn’t binding on Kenya, Kenya has jurisprudence on the issue of right to health superseding intellectual property rights. In Petition 409 of 2009, the petitioners sought a declaration that right to health includes the right to access affordable medication including generic medicines
They therefore sought a ruling that parts of the Anti-Counterfeit Act 2008 was unconstitutional as the petitioners would be denied access to essential drugs. The court upheld the petition.
The prevailing law in Kenya therefore is that right to life and health supersede intellectual property rights. This presents a further argument against granting DNA patents in medical research.