Gene meets machine: intellectual property issues in bioinformatics.

• Author: D'Souza, Suneeta

Introduction

"Bioinformatics" is the new technology buzzword used to describe a rapidly developing discipline lying at the intersection of computer technology and the life sciences. These days, it is virtually impossible to pick up a popular science magazine and not find something about bioinformatics. Although there is currently no widely agreed upon definition for the term "bioinformatics", it may be defined as "the application of computing power to biological data to reveal new patterns and information below the surface of those data." (1) Bioinformatics is currently being applied to a number of scientific areas including chemistry, genomics, brain mapping, pharmacology, proteomics and structural biology.

A key aspect of these new bioinformatic technologies is the creation and maintenance of databases for the storage of biological information. In addition, stemming from the enormous growth over the past two decades in the amount of biological information available to scientists, including the success of the Human Genome Project, is the urgent need for the interpretation, integration and analysis of such information. This integrative aspect of bioinformatics is important in determining the meaning and usefulness of the data, and involves tasks such as locating particular genes in the genome sequences of a variety of organisms, creating methods to predict the structure or function of gene sequences, grouping protein sequences into families of similar or related sequences, and comparing and aligning protein sequences in order to identify evolutionary relationships. (2) A practical example of this integrative aspect of bioinformatics is using a computer program to analyze gene sequence data in order to determine how a gene related to a particular disease is turned on or off in the cell. This type information would be very useful in the realm of drug discovery and development.

The ability to use bioinformatics to organize, analyze or make predictions from data collected in the lab has had a major impact on biological research by reducing the time required to find solutions to certain biological questions. (3) With this potential to dramatically reduce the time to discover an important drug or treatment for a disease, it is not surprising that in the last few years a great deal of intellectual and financial resources, both in the private and public arenas, have been poured into the development of bioinformatic tools, particularly in the areas of genomics and proteomics.

With this influx of money and intellectual effort into the study of bioinformatics, the issue of intellectual property protection for these new technologies is an important one to consider. While existing forms of legal protection may be already be available for some bioinformatics technologies, the question arises as to whether the existing law needs to be expanded, and whether new forms of protection should be introduced, in order to ensure adequate protection for those parties involved in commercial research endeavours.

These questions become more difficult to answer when one considers the extent to which the advancement of the science of bioinformatics depends on the open and collaborative sharing of data and research tools. That is, with increased intellectual property protection, it is possible that the notion of "open science" in bioinformatics will be unattainable, and such an outcome may have many profound effects on future discoveries in bioinformatics. This paper will attempt to provide a discussion of some key intellectual property issues in bioinformatics, including a consideration of how such proprietary issues may impact the science of bioinformatics as a whole.

Intellectual Property Protection in Bioinformatics

Bioinformatics has clearly emerged as a key player in the realm of biomedical sciences and pharmaceuticals. The bioinformatics field continues to grow rapidly, and companies investing time and money in this area will likely see the need for adequate intellectual property protection for such technologies as a key issue. In fact, it is often argued that the continued advancement of the field of bioinformatics movement is highly dependent on the ability to obtain intellectual property protection, and particularly patent protection, for such innovations. That is, although intellectual property protection is often thought of in terms of the owner's ability to exclude others from using or selling a particular product or process, it has been suggested that the ultimate goal may perhaps be to attract further investment in research and development. (4) Thus, without the possibility of intellectual property protection, it has been argued that people are less likely to invest large amounts of time and money into new technologies.

Furthermore, it may be argued that intellectual property protection encourages further discoveries and advances. For instance, a patent owner gets the right to prevent others from making, using or selling an invention for the term of the patent in exchange for a full description of the invention being made available to the public, thus allowing other researchers to benefit from the advances. As such, the ability to protect intellectual property in a given area of research may be thought of as a way to maintain both the financial and intellectual momentum, which in turn stimulates further technological advances.

However, while it is possible that increased legal protections for bioinformatics inventions may result in such benefits, these may appear to come with corresponding costs as one considers the ways in which the science of bioinformatics may be impacted by such proprietary protections. It may be argued that the notion of intellectual property protection imports into the bioinformatics landscape a number of potential barriers to the notion of "open science," such as reduced access to genetic data and software tools, with the potential to seriously impede future bioinformatics discoveries. Is it possible to strike a balance between these competing interests? Before delving into such a debate, it is useful to first examine the existing modes of protection that may be used in respect of bioinformatics technologies.

Intellectual property protection for bioinformatics inventions is a largely untested area in Canadian and U.S. law. (5) However, it is clear that ability to obtain intellectual property protection in any given area of bioinformatics depends on the type of bioinformatic tool involved. Analyzing stored genomic and proteomic data requires the use of biological databases, and often involves the use of complex and sophisticated "data mining" tools such as complicated search algorithms and statistical analyses in order to sift through the mass of information. In addition, complex software applications are often used to predict the structure or interaction of biological molecules. While some of these technologies may fit into the existing framework of intellectual property law, others may fall outside of the scope of current legal protections. These issues will be discussed in the following section.

Bioinformatics Databases

Databases play a key role in bioinformatics for the collection, storage and maintenance of biological data. Databases and the information contained in them are often thought of as both products of research, as well as important precursors for future biological discovery. However, databases per se, existing simply as collections or arrangements of raw data, are generally not patentable subject matter. That is, a database consisting of a gene or protein sequence is patentable only to the extent that the data itself contained in the database is patentable.

Patent legislation in both Canada and the United States set out the criteria required to patent an invention. In both Canada and the U.S., the respective legislation require that for an invention to be patentable, it must be a new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement thereof. (6)

All patentable inventions, including those in the field of bioinformatics, must first fall within the statutory subject matter. The Canadian Patent Act states that a patent will not be granted for any mere scientific principle or abstract theorem. (7) Furthermore, the U.S. Supreme Court has identified several types of non-patentable subject matter: laws of nature and natural phenomena, and abstract ideas. (8) In addition, a mathematical formula or algorithm that is viewed in the abstract is considered unpatentable subject matter. (9)

Assuming that a given invention falls within the proper statutory subject matter and has both novelty and utility, in order to be patentable the invention must also have inventive ingenuity or "non-obviousness". (10) Generally speaking, the standard for non-obviousness requires that a patentable invention be sufficiently different from the prior art such that a person "skilled in the art" would not have considered the invention to be obvious at the time it was made. Although this test has been suggested to provide a somewhat objective standard for measuring the obviousness of a given invention, its subjectivity is inevitable and it is perhaps the most difficult test for patentability to satisfy. (11)

In general, matter in its naturally occurring state cannot be patented, but an isolated and purified product of nature can be. (12) Thus, it is possible for certain isolated and purified DNA sequences that are separate from the chromosomes in which they exist in nature, or DNA sequences that are created by recombinant means, to be patented if all the statutory requirements (novelty, utility and inventiveness) are met. However, raw, nonfunctional, descriptive...