Intellectual Property Strategy in Bioinformatics and Biochips
Fernandez, Dennis, Chow, Mary, Santa Clara Computer & High Technology Law Journal
What are the fields of bioinformatics and biochips? These are relatively new disciplines that have gained much recognition in the past few years. Basically, bioinformatics is the convergence of analytical and computational tools with the discipline of biological research. This has vast influence in biological research, as numerous data that are collected through laboratory experiments can be organized and analyzed, and predictions can be made to reduce the time spent in finding cures for the causes and cures of diseases. Additionally, biochips pertain to primarily semiconductor-based devices used for biological or other healthcare-related applications.
The amount of data collected in biological research is tremendous especially in the area of genomics. On June 26, 2000, a group of scientists announced the completed survey of the human genome--the sum total of all the genes in each cell of the human body. (1) The genome is the entire genetic blueprint for a human being written in the alphabet of chemical compounds called nucleotides: adenine (A), guanine (G), cytosine (C), and thiamine (T). (2) A gene is the specific sequence of the nucleotides that tells the body how to create proteins that maintain cellular structure of the organism and direct the functions of the cell. (3) The human cell has some 100,000 genes that are specific sequences of DNA and the sum total of all units of nucleotides results in a mind-boggling 3.1 to 3.2 billion base pairs in the human genome. (4) However, only 3%-5% of the genome contains genes, which in turn produce four to five proteins. These few protein molecules control all of life's major functions. (5) Thus, computational technology is required in the sequencing of the database, the studying of the functions of the specific sequence (gene), and the management and dissemination of the genetic information.
With the potential pay-off of finding a blockbuster drug or treatment, a copious amount of funding, both private and public, has gone into the development of bioinformatic tools as well as related biochip applications in the genomic space. With all the money going into these bioinformatic and biochip companies, these companies need to protect their technology. In 1999 alone, for example, 289,448 patent applications were filed in the bioinformatic field and the United States Patent and Trademark Office (USPTO) has created working groups to deal with the influx of bioinformatic applications. (6) Although patents in these areas have increased and provided an avenue to protect one's intellectual property in this discipline, controversy surrounds the patenting of various technologies in the field. For one, the thought of allowing a company to patent and have a monopoly over a gene sequence that has been around since the beginning of life is quite disturbing. On the other hand, the discovering and developing of a new gene-based pharmaceutical product in the United States requires years of commitment and immense capital resources, possibly in the realm of $500 million. (7) Without the protection of the patent system, these companies would have no means of recouping these capital and time investments, and innovation would be put to a halt. (8)
II. INTELLECTUAL PROPERTY PROTECTION IN GENOMIC DISCIPLINE
Within the genomic discipline, companies and research can be divided into three areas: 1) sequencing the genome, 2) functional genomics, which is finding the functions of the genes, and 3) information systems, which is the software tools that manage and present the tremendous amount of data. Additionally, various biochips technologies, such as micro-arrays, are deployed in cooperation with such genomic tools. For each area, different technology is generated and thus, a different intellectual property strategy should be deployed. Often, companies participate in one or more of the areas and should pursue a joint strategy.