Bioinformatics innovations and patent eligibility

• Author: Ramesh B. Karky
• DOI: http://doi.org/10.1111/jwip.12101
• Date: 01 July 2018
• Published date: 01 July 2018

DOI: 10.1111/jwip.12101

ORIGINAL ARTICLE

Bioinformatics innovations and patent eligibility

Ramesh B. Karky

Vrije Universiteit Brussel, Centre for Economic Law and Governance, Elsene, Brussels, Belgium

Correspondence

Ramesh B. Karky, Vrije Universiteit Brussel,

Centre for Economic Law and Governance,

Pleinlaan 2, 1050 Elsene, Brussels, Belgium.

Email: rkarky@vub.ac.be

Bioinformatics technol ogy (combination of biolo gy and

information technology ) is worthy of special consid er-

ation in terms of intellectu al property. Bioinformatic s

inventions have brought u p many uncertainties ove r the

issue of patent eligibilit y. There is neither any specif ic

bioinformatics law nor any co urt has adjudicated any

disputes related to bioinformatics. This paper critically

examines bioinformatics-related patent laws and practi-

ces and analyzes whether pa tent laws protect bioinf or-

matics innovations partic ularly software which analy ze

DNA sequences.

KEYWORDS

bioinformatics-software, patent eligibility

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INTRODUCTION

Bioinformatics is a rapidly developing area in the field of technology, with the potential for new inventions beyond our

imagination. Today, genetic information is freely available online from the databases developed and maintained by

various research institutions and bio-ventures. The availability of vast amount of information about the human

genome has increased the potential of bioinformatics inventions. The identification of the function of a gene, through

DNA analysis using sophisticated laboratory techniques and complex computer algorithms, will allow for the

development of useful products such as pharmaceuticals and therapeutic drugs, among other advancements. There is

no specific bioinformatics law as such, and no court has adjudicated any disputes related to bioinformatics. Except for

a few advanced countries, many countries have no bioinformatics technology. Due to its special nature (combination

of biology and information technology), bioinformatics is worthy of special consideration in terms of intellectual

property.

Bioinformatics inventions have brought up many uncertainties over the issue of patent eligibility. Some

bioinformatics inventions can utilize a composition of matter or article of manufacture claims, whereas most

© 2018 The Authors. The Journal of World Intellectual Property © 2018 John Wiley & Sons Ltd

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wileyonlinelibrary.com/journal/jwip J World Intellect Prop. 2018;21:140–156.

bioinformatics inventions are software processes. Bioinformatics software patents are among the most difficult

protections to obtain. This paper surveys and crit ically examines bioinformatics-related patent laws and

practices in the US, Canada, the EU, Australia, and Japan and analyzes whether bioinformatics innovations are

protected by patent laws. This paper addresses the issues relating to the patent eligibility of bioinformatics

innovations.

This paper has been organized into four parts. The first pa rt (general introduction to bioinformatics) pr esents

the definition of bioinforma tics, its possible areas of appl ication or use, and the role of gen e and genetic

information in bioinformat ics inventions. The second pa rt (bioinformatics and datab ases) discusses relevant

databases and situations whe nsu ch databases can be patent-eligible. The third part ( bioinformatics invention and

patent eligibility) exami nes whether computer-i mplemented bioinformati cs inventions are patent- eligible and

protected by patent laws in t he US, Canada, the EU, Japan, an d Australia and further ex amines each countries'

testing methods for grantin g patent to bioinformatics in ventions. This part covers bi oinformatics software , the

impact of the Alice decision on bioinformatics innovati ons, and open source. The fou rth part presents the

discussion and conclusion of this pa per.

The relevant patent laws and practices of the US, Canada, EU, Australia and Japan have been chosen for

discussion in this paper as these countries have bioinformatics technology. Most developing countries and least-

developed countries have no bioinformatics technology; thus, it is not possible to survey every country's relevant laws

in this paper.

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GENERAL INTRODUCTION TO BIOINFORMATICS

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Definition

There is no single and well-accepted definition of the term “bioinformatics.”The scope of this term's use is still being

debated within the biological and computer science communities. To some, bioinformatics and computational biology

are one and the same, and both are defined as any use of computers to process any biology-derived information and

characterize the molecular components of living things (Bioinformatic.org, 2017). To others, bioinformatics relates to

computer science, that is, information science or technology, where the information contained within biological data is

emphasized (Bioinformatic.org, 2017). In practice, a combination of the two concepts appears to have gained wide

acceptance among scientific communities.

Paulien Hogeweg had used the term “bioinformatics”for the first time (Cuticchia, 2013, 1). She writes, “In the

beginning of the 1970s, Ben Hesper and I started to use the term ‘bioinformatics’for the research we wanted to do,

defining it as ‘the study of informatics processes in biotic systems’” (Hogeweg, 2011).

Biologists use computers to analyze, store, retrieve and predict the composition or structure of

biomolecules, which include genetic material (nucleic acids) and the products of genes (proteins) (Bioinformatic.

org, 2017). Fredj Tekaia defines bioinformatics as “the mathematical, statistical and computing methods that

aim to solve biological problems using DNA and amino acid sequences and related information”(Bioinformatic.

org, 2017).

On 17 July 2000, the US National Institutes of Health (NIH) issued a working definition of Bioinformatics

and Computational Biology. It states that the two disciplines are rooted in life, computer and information

sciences and technologies and draw from mathematics, physics, engineering, biol ogy and behavioral sciences

(BISTIC Definition Committee, 2000). The NIH defines bioinformatics as “research, development, or application

of computational tools and approaches for expanding the use of biological, medical, behavioral or health data,

including those to acquire, store, organize, archive, analyze, or visualize such data”(BISTIC Definition

Committee, 2000). Another definition, suggested by Gaff, Loren, and Dickson (2013) states that bioinformatics

is “the use of information technology in the analysis and organization of data relating to biology”(15). In other

KARKY

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