Bioinformatics is quickly growing and improving in the contemporary information technology era, because to the large database systems available and the growing amount of biological data being published. Because of the perceived importance of bioinformatics databases, many countries, notably the United States, Japan, and India, have invested significant resources in studying and building bioinformatics databases, with government funding.

In the fields of biological sciences and pharmaceuticals, bioinformatics has become increasingly significant. It is frequently suggested that the discipline of bioinformatics' continued progress is greatly dependent on the capacity to get intellectual property protection, particularly patent protection in specific fields. As a result, it has been suggested that without intellectual property protection, people are less likely to invest huge sums of money and effort in innovative technology.

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Bioinformatics: Meaning and Significance

On a larger scale, it is believed that information would aid in the finding of remedies for various diseases as well as the understanding of the genetic causes of disease. To grasp the nature and impact of findings, a brief detour into the fields of genetics and molecular biology is required. The most fundamental component of the human body is DNA, which is the medium through which hereditary features are passed down from generation to generation. DNA is made up of nucleotides, which are repeating units. DNA is the material that makes up genes. The nucleotide is a subunit of DNA that expresses itself by its organization. The nucleotides that make up DNA are made up of four main types.These nucleotides are found in diverse combinations throughout the DNA molecule's structure. Because genes are made out of DNA, they are manifestations of different combinations of these four nucleotides. Through diverse permutations and combinations of these four fundamental nucleotides, the enormous variety of genes that determine a wide range of features in species is possible. In effect, all genes are variations on the four fundamental nucleotides (adenine (A), guanine (G), cytosine (C), and thymine (T)). These genes tell the body to make proteins that keep the organism's cellular structure intact and direct the cell's function. Many diseases that afflict the human body are caused by faulty enzymes or other malfunctions in the body's processes.Proteins are the building blocks of enzymes.  As a result, comprehending the nature and composition of a protein will aid in comprehending the nature and molecular causes of disease incidence. Proteins, in turn, are influenced by a variety of genes. As a result, at the most fundamental level, a better understanding of genes may aid in the research of human diseases and potential remedies. The real scope of this field's discoveries is mind-boggling. Each gene is a specific and unique sequence of DNA in the human cell, which is estimated to have close to 100,000 genes. These genes create proteins that control all of life's major processes.As a result, there is a clear need for a technique or application that will principally assist in the categorizing and sequencing of all this voluminous data. At the secondary level, applications and technologies that aid in the research of particular genes and their roles are required. The primary necessity, as stated in the strictest sense, is the reason for the emergence of bioinformatics. The secondary demand has resulted in the creation and spread of programmes and software that assist in the analysis of the data gathered thus far. The term "computational biology" is often used interchangeably with "bioinformatics." Most authors on the subject use the term bioinformatics to refer to applications that include both fundamental data categorization and administration as well as data analysis and comparison. Though this was the original goal of computational biology, bioinformatics has developed to include analysis and interpretation of various types of gene-related data, including nucleotide and amino acid sequences, protein domains, and protein structures.

Intellectual Property Protection for Bioinformatics Databases

"To qualify as patentable subject matter, the biological sequence must be characterized as a process, machine, or device," according to Diamond v. Diehr  450 U.S. 175 (1981), "and the notion of itself is not patentable, nor the principle in the abstract."  This opened up new opportunities for people working in the field of bioinformatics because methods for finding specimens, manufacturing tools, and the tools themselves, including products, could no longer be patented because it was clear what should be protected under IP law, but there were still issues with other aspects of the field. Biology and intellectual property rights go hand in hand, thus it's no surprise that bioinformatics and intellectual property laws would have a close relationship. Not only because Bioinformatics combines biology and technology, but also to safeguard biological information uncovered by Bioinformatics professionals and prevent misuse of that information. So, for Bioinformatics to survive in the market, IP laws are critical because practically all components of the field are patentable, and now that all aspects are patentable, there is also the possibility of generating IP value by investing in research and tools. The scope of bioinformatics protection can be separated into two categories.The first are bioinformatics tools such as databases and raw data compilation, and the second are tools that aid in data retrieval and analysis. Though the scope of IP protection in Bioinformatics is divided into two parts, there are many issues related to Bioinformatics on the IP front, including computer software and biological research, genetics and genome databases, algorithms and computational techniques, the concept of interoperability between existing databases, biological molecules, and, most importantly, the research data itself. So, how are they all going to be protected? Bioinformatics' many components can be secured in a variety of ways:

Patents can be used to gain monopoly over bioinformatics-related technologies;

1. Trademarks can be used to protect company names, domain names, product names, service marks, and slogans;
2. Copyrights can be used to protect Bioinformatics-related materials such as books, articles, software codes, and so on;
3. Trade Secrets can be used to protect compilations, databases, facts, formulas, and processes.

It's simple to safeguard tools, technologies, facts, formulas, and anything else generated by humans in the field of Bioinformatics, but what about biological databases? Biological databases are collections of information gleaned via considerable research, analysis, and comprehension of biological specimens and life science. The primary database and secondary database are the two types of databases. Experimentally produced data, such as nucleotide sequences, protein sequences, and macromolecular structure, are used to populate primary databases. Researchers enter experimental results directly into the database, and the data is virtually archival in nature.Secondary databases, on the other hand, contain information produced from the analysis of primary data. Curated databases are a common term for them. The first question was whether primary databases should be protected under IP laws or not, because they are something on which a lot of money has been spent and a lot of effort has gone into the research to compile the database, resulting in the databases being protected under IP laws so that they can be commercialized and misused. The government wants it to be open to the public so that researchers can benefit from it, but the private sector has a different opinion. The fight is hard and long, and it seems to go on forever.As a result, primary databases should not be made available to the general public. This is for three reasons: 

1. A significant number of major databases are sponsored by the government and rely on the revenue generated by taxes, and hence should be made freely available to the public; 
2. IP protection for key databases will have a significant impact on the foundations of life science research, as these databases are critical to researchers in the fields of gene engineering, molecular biology, and proteomics. The utilization of open databases will facilitate communication across research teams and eliminate time-consuming and costly repetition.
3. It’s difficult to pinpoint the source of data in key primary databases because it's contributed not just by the database's creators, but also by current life science researchers.

Patentable Technologies in Bioinformatics

Although databases are not patentable in and of themselves, patent protection may be granted for database-related inventions. A software invention is patentable in the United States if it meets all of the requirements for software patents. Previously, I.P. protection for software was not possible because it did not fall under the category of patentable subject matter.

However, in State Street Bank & Trust Co. vs. Signature Financial Group Inc.(149 F.3d 1368 (Fed. Cir. Jul. 23, 1998), the United States Federal Circuit Court of Appeal substantially modified the law in this software patent field, which could have a significant impact on the bioinformatics business.The Supreme Court ruled in the State Street Case that mathematical algorithms are patentable if they produce a "useful, concrete, and tangible result," and that the mere fact that the claimed invention involves inputting, calculating, and storing numbers does not make it non-statutory subject matter unless it produces a tangible result. Software and algorithms that meet the conditions are patentable in the United States, according to this case law.

Schlumberger Canada Ltd. v. Canada (Commissioner of Patents)( [1981] F.C. 845) was the leading court ruling in Canada, where algorithms employed in software programmes to generate protein sequences, shapes, locations, and functions may also be applicable. As a result, it is clear that bioinformatics patents are permissible under present patent law.

Conclusion

Bioinformatics is a field that brings together cutting-edge discoveries and advancements in molecular biology and genetics with fledgling information technology and computer science. The amount of creativity that occurs in this interdisciplinary field of study is incredible. When it comes to protecting one's hard work and revenue, the fields of bioinformatics and intellectual property regulations are inextricably linked. Because of the field's rapid expansion, there are several potentials to attract more patent applications and encourage Indian biotech businesses as well as companies from other continents to participate in the Indian economy. This will not only increase awareness of India's biotechnology regime, but it will also aid in economic growth, resulting in India's development as well as the development of patent agents' ability to file and handle IPR and biotechnology cases.

Author: Anuja Saraswat - a student of NMIMS Kirit P. Mehta School of Law (Mumbai), in case of any queries please contact/write back us at support@globalpatentfiling.com or Global Patent Filing.