Abstract: Bioinformatics is an ever-growing field due to the availability of vast database systems and increasing biological data. This rapid development deals with research and development activities and requires adequate protection in the form of Intellectual Property Rights(IPR) as it adds value to the discoveries and provides incentives to the investors. The study includes the role of IPR in bioinformatics with a major focus on patents and related laws. The paper will also analyze, what types of bioinformatics are patentable, how does patents protect bioinformatics innovations specifically software which analyses DNA sequences. The paper will be presented in four parts namely, part one will consist of the introduction, while part two will focus on what is bioinformatics and how it is related to IPR, part three will focus on the patent eligibility criteria for bioinformatics and lastly, part four will present a conclusion.

Keywords: Bioinformatics, patents, omics, DNA sequence, Intellectual property rights.

A. Introduction

The rapid developments since the last two decades in the field of biotechnology have resulted in new methods, products for the advancement of many sectors such as the pharmaceutical industry, diagnostics, environment, food tech, agriculture2. Recent sequence explosions all around the globe have also resulted in sequencing the whole genome of microbes, animals, plants while along with the explosion of sequence issues of patents about deoxyribonucleic acid(DNA) and ribonucleic acid(RNA) and other related technologies3. Nowadays, the vast amount of information about the human genome has increased the potential of bioinformatics innovations worldwide as it is available online free in the databases maintained and developed by various bio-ventures and research organizations. Bioinformatics has many uncertainties when it comes to patent eligibility, some can utilize a composition of matter or is a product of manufacture claims but the most common bioinformatics innovations are in the field of software processes which is difficult to obtain4. DNA and gene-related technologies are influencing and encouraging medical research which provides solutions to various incurable diseases and the development of safe and efficient drugs that are affordable.

Biological data is growing at a fast speed, for example, the number of sequences in GenBank Increased from 606 in 1982 to 201,663,568 in 2017 and it doubles its size every 15 months5. Bioinformatics is used in numerous areas such as gene therapy, drug development, molecular medicine, preventive medicine, crop improvement, insect resistance studies, etc. Determining the function of a gene can help in making pharmaceutical drugs, but to ascertain the function of a gene DNA must be analyzed in sophisticated laboratory techniques and complex computer algorithms6. Genome research aims at the analysis of proteins that are encoded by particular DNA sequences, single nucleotide polymorphism (SNP) analyses, and the mutation of genes that are associated with the disease7. For example, treatment of a fungal infection, the researcher might examine its DNA or mRNA by sequencing which results in a list of genes in the human genome and remove the unwanted genes.

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