10 Bioinformatics Materials and Issue of Patentability (*)
Invited Researcher: Ramesh Bikram KARKY (**)
Bioinformatics is an important field of biotechnology. With the advancement of bioinformatics, theconventional laboratory-based biotechnology has been transformed into a computer-based science.
Bioinformatics is able to bring new inventions which are far beyond the scope of conventional laboratory based
biotechnology. Bioinformatics has brought various significant advancements in biotechnology field. It is an
important area of invention which directly effects human health and other areas of human life. This research
addresses the issue related to the patentability of bioinformatics materials. On this issue, different jurisdictions
have different approach. Many jurisdictions have not even touched this subject matter. Further research,
investment, and development in bioinformatics field will depend on its ability to obtain patent protection. This
research critically examines the patentable aspects of bioinformatics materials, i. e., biological sequences,
sequences database, and software. It surveys related patent laws and practices of Japan, the US, Europe,
Canada and Australia, and it analyzes whether bioinformatics innovations are protected by patent in thesejurisdictions; similarity and contradictions of patentability aspects of bioinformatics materials between different
jurisdictions; its interrelationship with the open source policy; and the issues of harmonization of this subject
matter.

I

GeneralIntroduction
Bioinformatics

toThere is no single and well accepted
definition of Bioinformatics. There is debate on
the scope of its use within the biological andcomputer sciences. To some, bioinformatics andcomputational biology are same, and both aredefined as any use of computers for processing
any biological-derived information, i. e., DNA
sequences, breast x-rays and other. To them,bioinformatics is a synonym for computational
molecular biology, i.e., any use of computers tocharacterize the molecular components of living
things.1 To others, bioinformatics relates to thecomputer science, i.e., information science and/or
information technology, and they emphasize theinformation contained within the biological data.2
However, in practice, it has been accepted as a
combination of both sciences.
Biologists use computer to store, retrieve,
analyze or predict the composition or the
structure of biomolecules. Biomolecules include
genetic material – nucleic acids – the products ofgenes: proteins. 3 Fredj Tekaia defines
bioinformatics as “The mathematical, statisticaland computing methods that aim to solve
biological problems using DNA and amino acidsequences and related information.”4
The National Institute of Health (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 thoseto acquire, store, organize, archive, analyze, or
visualize such data.” 5 Brian M. Gaff, Ralph A.
Loren, and Gareth Dickon define bioinformatics as,“…The use of information technology in theanalysis and organization of data relating tobiology.”6
Bioinformatics can be used in various fields, i.
e., molecular medicine, personalized medicine,preventive medicine, gene therapy, drug
development,
crop
improvement,
insectresistance, improve nutritional quality, and manyother.7 “Every disease has a genetic component.
… The completion of the human genome meansthat we can search for the genes directly
associated with different diseases and begin tounderstand the molecular basis of these diseases
more clearly. This new knowledge of themolecular mechanisms of disease will enable
better treatments, cures and even preventative
tests to be developed.”8 “The potential for using(*) This is a summary of the report published under the Industrial Property Research Promotion Project FY2013
entrusted by the Japan Patent Office.
(**) Postdoctoral Fellow, University of Western Ontario, Canada
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genes themselves to treat disease may become areality. Gene therapy is the approach used to treat,cure or even prevent disease by changing theexpression of a persons’ genes.”9 “The arrival of
the complete genome sequences and theirpotential to provide a greater insight into themicrobial world and its capacities could havebroad and far reaching implications forenvironment, health, energy and industrial
applications.”10

Ⅱ Bioinformatics in the US, Canada,
EU, Japan and Australia
In general, bioinformatics materials include
biological sequences (DNA, RNA, Proteins),sequences database and software. Biologicalsequences are generally stored in database andcomputer software analyzes these biologicalsequences database. In the following paragraphs,
this research examines whether biologicalsequences, sequences database and software areprotected by patent or not in the US, Canada, EU,
Japan and Australia.
1

Biological Sequences (DNA, RNA, Proteins)

For a long time, there is ongoing issue ofpatentability of modern biotechnology. The doubt
has been expressed on the applicability of
traditional principles of patentability to a new anddifferent form of technology. 11 DNA is not a
product, but carries information.12 However forthe purpose of patentability, DNA is consideredanalogous to chemical compounds. 13 There isalso the insufficiency of written forms ofdescription which is required to ensure a third
party’s ability to repeat an innovation.14 Physicaldeposit of lower life forms in depositing agency is
considered to meet the requirements ofenablement and disclosure.15 Justin Pila further
writes, “Accommodating modern biotechnology
within the patent system on the basis of its
equivalence to new chemical compounds is
problematic because, at a fundamental level, nosuchequivalence
exists.
However,
accommodating modern biotechnology within thepatent system as information is also problematic
because information, according to traditional
patent jurisprudence, is not a subject matter thatpatent law protects.”16 There is also a question oflacking of novelty because of their prior existence
and lacking of inventiveness because of theirderivation from natural conditions. 17 Patenting
modern biotechnological invention has been

criticized as unethical, immoral, or contrary to
public policy, and also it gives inappropriatemonopolies to living organisms.18
Jurisdictions which allow patenting to DNA
have also no similar standing. In the US, after 30
years of granting patents to genes, the question of
the patentability of genes was considered again by
the US Supreme Court. On June 13, 2013, the US
Supreme Court ruled that, “[a] naturally
occurring DNA segment is a product of natureand not patent eligible merely because it has been
isolated, but cDNA is patent eligible because it is
not naturally occurring.” 19 Canada has been
granting patent to DNA. In 2002, the Supreme
Court of Canada in Harvard College v. Canada(Commissioner of Patents) case ruled that higher
life-forms of animals and plants were notpatentable subject matter while microorganisms(cells and genes) were patentable.20 In Europe,
the patentability of isolated genes is expressly
acceptedinEuropean
law
after
the
implementation of the Directive on the Legal
Protection of Biotechnological Inventions (EUBiotechnology Directive) in 1998.21 In Japan, theJapanese Patent Act defines invention as a “highly
advanced creation of technical ideas utilizing thelaws of nature.”22 The “technical idea” must havea certain degree of concreteness, operatives orrepetitiveness and may not simply be a discovery
of a “law of nature”. 23 Biotechnologicalinventions including isolated DNA are patentable
in Japan.24 In Australia, “The building blocks ofliving matter, such as DNA and genes (including
human DNA and genes) which have for the firsttime been identified and copied from their natural
source and then manufactured synthetically as
unique materials with a definite industrial use”25
are not deemed to be a discovery. 26 Whether
human gene (isolated DNA) is patentable or nothas been under consideration before the Supreme
Court of Australia. However, after the Myriad
decision in 2013, 27 the standard of isolated DNA
patenting has been changed and it is no more
patentable subject matter in the US. We will see
what course the EU and Japan will take on thispatentable issue in the near future.
2

Sequences Database

Bioinformatics databases in general aresequence databases (DNA, RNA and protein
sequences). In addition to the sequence database,
there are databases on gene mapping, protein
structure and literature citations.28 There is no● 2 ●● 79 ●IIPIIP
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Canada, Japan and Australia, but the EU has the
Directive on the Legal Protection of Databases.29
The database law (sui –generis system) protects
bioinformatics data or the contents of thedatabase. To qualify for database law protection, it
needs to meet the requirements of qualitative or
quantitative investment of a substantive nature
while obtaining the data or verifying the data orpresentation of the contents of the database. This
European database protection is available only to
EU citizen. 30 Copyright cannot provide direct
protection to bioinformatics database, but
compilation of such date can be subject of
copyright protection.31
3

Software

It is the computer software which analyzes
biological sequence database and invent new
medicine or crops or plants or solve biologicalproblems. Biologists use computer to store,
retrieve, analyze or predict the composition or
the structure of biomolecules. Biomolecules
include genetic material – nucleic acids – theproducts of genes: proteins.32 It is important to
identify the function of a gene to develop usefulproducts such as pharmaceutical products. To
identify the function of a gene, we need to analyze
DNA, and the techniques for analyzing DNA
includebioinformatics
using
information
processing by computer among other. 33 Hence,the patent protection to bioinformatics software isimportantforfurtheradvancementofbioinformatics.
In the US, computer program as such is not
excluded from patentable subject matter by law.
Computer software is patentable if it meets thestatutory requirements for all patentable
inventions. 34 In 1998, the US Federal Circuit
Court of Appeals in its decision in the State Street
Bank & Trust Co. v. Signature Financial Group
Inc.35 case ruled that mathematic algorithms waspatentable if they produce a “useful, concrete andtangible result.”36 In 2008, the US Federal Courtof Appeals changed its previous test “useful,concrete and tangible result” and held in its
decision in the In re Bilski37 case that in order tobe eligible patent subject matter the claims must
either tie a business method to a machine, or
representatransformation(e.g.,
themachine-or-transformation test). 38 In 2010, theUS Supreme Court in Bilski v. Kappos39 case heldthat the machine or transformation test is a

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In Canada, computer software is patentable.
It needs to meet statutory requirements ofpatentability,i.e.,novelty,utilityandnon-obviousness and the software must be stored
on a physical memory to obtain patent protection.
Basically, the computer software needs to provide
a “technological solution to a technologicalproblem” to be considered as patentable.
European approach towards patenting of software
invention is different than the US. Computer
program “as such” are not patentable in Europe.
To be eligible for patent protection in Europe, acomputer implemented invention should solve atechnical problem in a novel and non-obvious
manner. 41 In Japan, computer program ispatentable. For computer program, copyrightprotection is available for the code. For method ofprocessing, patent protection is available for new
innovations if it meets patent requirements. For
patent protection being granted, software
program is required to be a creation of technicalideas “utilizing a law of nature.” According toStandard for Software, this requirement istypically met by “concretely realizing theinformation processing performed by thesoftware by using hardware resources.”
Bioinformatics generally involves information
processing by using hardware resources. In
Australia, pure or abstract methods of doing
business are not considered to be patentable, but
if the method is implemented using a computer, it
is patentable. Although they may have different
test methods, the US, Canada, Japan, EU andAustralia have been granting patent tobioinformatics software.

Ⅲ Similarity and Contradictions
BetweenJurisdictions
andRequirement of International
Harmonization
Regarding granting patent protection to thebioinformatics materials, there are somesimilarity and some contradictory provisions
among the patent laws of the US, Canada, EU,
Japan and Australia. Their patent laws andpractices on gene patenting differ to each other.
The US, Canadian and Japan patent laws haveneither written provision on DNA patenting nor
any provision of exclusion from patentability. In
the US, gene was granted patent protection for● 3 ●● 80 ●

the first time by court decision. 42 However, in
2013, the US Supreme Court in Myriad case ruled
that, “[a] naturally occurring DNA segment is a
product of nature and not patent eligible merely
because it has been isolated, ….”43 The current
US position does not allow granting patent toisolated DNA. Whereas the EU has written legal
position and says that isolated DNA is patentable.
It is furthermore related to DNA patenting,the EU and Australian patent laws have provisionof exclusion. The European Patent Convention
states, “Methods for treatment of the human or
animal body by surgery or therapy and diagnostic
methods practiced on the human or animal body”
are excluded from the patentable subject matter.44
The Australian Patent Act states, “human beings,
and the biological processes for their generation”
are excluded from patentability. 45 Whereas the
US, Japan and Canadian patent laws have no such
written provision of exclusion from patentability.
The EU and Japan have provision of publicorder and moral where any DNA related invention
contrary to public order and moral are considered
as non-patentable. Australian patent law has also
such provision where new invention the “use ofwhich would be contrary to law” isnon-patentable.46 Whereas the US and Canadianpatent laws have no such provision of public orderor moral.
In Europe, software inventions are treateddifferently than in the US. Software inventions
are excluded from patentability if they arecomputer programs “as such.” For the software
patentability, inventor needs to claim more thanjust a program for a computer and the invention
needs to be tied to hardware.47 In the US, there
is no legal provision which excludes patentabilityof computer program as such. Computer software
is patentable if it meets the statutory
requirements for all patentable inventions. 48
Japan, Canada, and Australia have also been
granting patent to bioinformatics software indifferent ground which we have alreadydiscussed.
In addition, there is no similarity of
constitutional authority in making patent law inthese jurisdictions. In Japanese Constitution,
there is no provision of authorizing legislative
power to Legislative body to make patent law
explicitly. The US Constitution authorizes patentlaw making power to Congress. The Constitutionof Canada authorizes patent law making
legislative power to the Parliament. 49 The
Australian Constitution authorizes patent law
making legislative power to the Parliament. 50
The European Patent Convention which is theauthority to grant patent to inventions is based ontreaty and not on any constitution as such.
On the issue of harmonization of patent laws
relating to biotechnological inventions, there is
criticism of any attempt at harmonizing patent law.
Justine Pila writes, “The problems created forpatent law by modern biotechnology are far fromresolved.” 51 She further writes, “The nature ofthose problems is such that formal attempts at
harmonizing patent law can only make themworse.” 52 The issue of the harmonization of
biotech patent law seems uncertain, because of
the controversy surrounding the biotech
patenting. 53 Even the European Patent
Convention (EPC) could not achieve successful
harmonization in Europe whereas the EPC wasaimed to harmonize patent law all over Europe.
Each member countries of different values andinterests have applied the provisions of EPC
differently.54 For example, EPC has provision of
DNA patentability whereas French law does notgrant patent to DNA.
On top of that the issue of international
harmonization of patent law is not supported byinternational law as such. In 1988, regarding thepatentability of DNA sequences, the European
Patent Office (EPO), the United States Patent andTrademark Office (USPTO), and the Japanese
patent Office (JPO) issued a statement:“Purified natural products are not regarded
as products of nature or discoveries because
they do not in fact exist in nature in an
isolated form. Rather, they are regarded forpatent purposes as biologically active
substances or chemical compounds andeligible for patenting on the same basis asother chemical compounds.”55
However, the position of this statement has
been changed after the decision of the US
Supreme Court in Myriad case in 2013. Now thelatest US version considers isolated DNA as a
discovery and not an invention. The approach of
biotech patenting and lack of conformity offundamental norm among them creates doubt of
harmonization.56● 4 ●● 81 ●

There is no international law obligation to

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patentlaws
amongvariousjurisdictions. It is also presumed that a state
would perform its international obligations ingood faith. Infringement of the international
obligation is not to be presumed.57 Internationallaw is indifferent as to how a state meets its
international obligations.58
The WTO Agreement and the TRIPS
Agreement have provision of compliance which isdifferent than international harmonization. The
WTO Agreement states:“Each Member shall ensure the conformityof its laws, regulations and administrative
procedures with its obligations as provided in
the annexed Agreements.”59
The TRIPS Agreement states:“Members shall give effect to the provisionsof this Agreement. Members may, but shallnot be obliged to, implement in their law
more extensive protection than is requiredby this Agreement, … Members shall be free
to determine the appropriate method of
implementing the provisions of thisAgreement within their own legal systemand practice.”60

Ⅳ Policy towards Openness
The science of genomics has been growing
up with different outlook than any other fields ofknowledge. Openness is the main operating
principle in the field of genomics. All genomic
data are freely available online. The spirit of thescientists who are working in this field havestrong urge to facilitate their invention freely toothers. Richard Stallman had epitomized the free
software movement, a vision of making softwaredevelopment a culturally enriching experience. 61
In the free software movement, software sourcecode is distributed in an open and free manner tofurther modify and improve software. 62 The“Creative Commons” movement” of Japan issimilar to the “Open Source” movement ofAmerica or Europe.63

Ⅴ Conclusion
Bioinformatics has brought revolutionarychanges in the fields of medicine, agricultural
crops, plants and others. The scientists who are
working in this field have less profit motive andmore motive of contributing to the society byoffering their works or inventions freely. The

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differently. The bioinformatics materials can beprotected by using patents, copyright and trade
secrets. Among available protections, patent
protectionisthebroadest
protection.
Bioinformatics software patent is one of the
difficult protections to obtain. Trade secrets may
be able to protect sequences database, but due tospecial nature of sequence database which are
publicly available, trade secrets law is noteffective to provide protection to sequences
database. Copyright law protects original
expression and it does not protect ideas orfunctionality of software programs. Copyright
may protect the source code of the computer
software program, but if such code has beenrewritten and is no longer similar to the originalcode, copyright protection will not be available.
1

http://bioinformatics.org/wiki/Bioinformatics (visited Dec.
16, 2013).
2
Ibid.
3
Ibid.
4
Fredj Tekaia at the Institute Pasteur available at
http://bioinformatics.org/wiki/Bioinformatics(visited
Dec. 16, 2013).
5
http://www.bisti.nih.gov/docs/CompuBioDef.pdf (visited
Dec. 16, 2013).
6
Brian M. Gaff, Ralph A. Loren, and Gareth Dickon,
Protecting Bioinformatics as Intellectual Property,
Computer and the Law, published by the IEEE
Computer Society, Jan. 2013 at 15 [Gaff et al].
7
Bioinformatics – Applications Areas, Bioinformatics
Resource Portal
Available at
http://bioinformaticstools.webs.com/application.htm(visited Jan. 16, 2014)
8
Ibid.
9
Ibid.
10
Ibid.
11
Justine Pila, Bound Futures: Patent Law and Modern
Biotechnology, 9 B. U. J. Sci. & Tech. L. 326 2003 at 328[Pila].
12
Ibid at 337.
13
Ibid at 334.
14
Ibid at 336.
15
Ibid at 336.
16
Ibid at 338.
17
Ibid at footnote number 71.
18
Ibid at 360.
19
Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,
569 U. S. at Pp. 10-18 (2013) [Myriad].
20[2002] 4 SCR 45 [Harvard College].
21
Directive 98/44/EC, of the European Parliament and of
the Council of 6 July 1998 on the Legal Protection of
Biotechnological Inventions, 1998 O.J. (L 213) 13, 21 &art. 17 [The Directive 98/44/EC].
22
Government of Japan (1959), Patent Act, Act No. 121 of1959, latest revision Act No. 109 of 2006 at art. 2(1)[Patent Act]. English translation, available at
http://www.cas.go.jp/jp/seisaku/hourei/data/PA.pdf.

● 5 ●● 82 ●

23

Kitagawa, Z. (ed.) (2006), Doing Business in Japan,
Chapter 16 Intellectual Property, Vol. 1, Newark, NJ:
LexisNexis, §16.02[2] at 16-8.
24
JPO (2005), Examination Guidelines for Patent andUtility Model, Part VII: Examination Guidelines forInventions in Specific Fields, Chapter 2 BiologicalInventions, Chapter 3 Medicinal Inventions, December
28, 2000, Latest Revision November 2005, English
Translation,
availableat
http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/t_to
kkyo_e/1312-002_e.htm.
25
Australian Government, Australian Law Reform
Commission, Patentability of Genetic Materials andTechnologies, para 6.34 [Australian Law Reform
Commission,
Patentability],
Availableat
http://www.alrc.gov.au/publications/6-patentability-gen
etic-materials-and-technologies/patentable-subject-matter (visited Feb. 10, 2014).
26
Ibid.
27
Myriad, supra note 19.
28
Junli Chang and Xuezhong Zhu, “Bioinformatics Databases:
Intellectual Property Protection Strategy,” Journal ofIntellectual Property Rights, Vol. 15, November 2010, p. 448[Chang and Zhu].
29
Directive 96/9/EC, 1996 O.J. (L 77) 20 [Directive
96/9/EC].
30
Chang and Zhu, supra note 28 at 448.
31
Elizabeth Howard and Gabriel Ramsey, “Bioinformatics
Databases: Questions of Copyright,” BioPharm
International, Nov. 2002, p. 46 [Howard and Ramsey].
32
Caroline McCubbin, “Legal issues in bioinformatics,”
Journal of Commercial Biotechnology, Vil 9. No 3. at
250, March 2003 [McCubbin].
33
Ibid at 208.
34
Charles Vorndran & Robert L. Florence,“Bioinformatics: Patenting the Bridge Between
Information Technology and the Life Sciences,” (2002)
42:1 IDEA 93 at 108 [Vorndran and Florence].
35
149 F. 3d 1368, 47 U. S. P. Q. 2d 1596 (U. S. Fed. Cir.
1998).
36
Vorndran and Florence, supra note 34 at 1374.
37
In re Bilski. 545 F.3d at 961-2 (Fed. Cir. 2008).
38
Karen Durell, Miller Thomson LLP, “Still Waiting to
Resolve the Fate of Business Method Patents,”
Information & Technology Law Newsletter (Info. Tech.
Nws. 2010-04) August 2010, (J. Fraser Mann, Editor)[Durell and Thomson].
39
Bilski v. Kappos. U.S., No. 08-964 (6/28/10).
40Isabelle Huys, Geertrui Van Overwalle and Gert
Matthijs, “Gene and genetic diagnostic method patentclaims: a comparison under current European and US
patent law,” European Journal of Human Genetics(2011) 19, 1104- 1107, at 1106 [Huys et al].
41
European law and practice, European Patent Office,Munich, Germany, 2013 at page 15 [European Patent
Office]. Available at www.epo.org.
42447 U. S. 303 (U. S. Sup. Ct., 1980) [Chakrabarty].
43
Myriad, supra note 19 at Pp. 10-18.
44
Convention on the Grant of European Patents, Oct. 5,
1973, 1065 U.N.T.S. 199 at art. 52(4) [The European
Patent Convention, 1973].
45
Patents Act 1990 (Cth) s 18(2).
46Patents Act 1990 (Cth) ss 18(2), 50(1)(a), 101B(2)(c), (d).
47
Gaff et al, supra note 6 at 16.

48

Vorndran and Florence, supra note 34 at 108.
Article 91 of the Constitution Acts, 1867 to 1982.
50
Australian Constitution s 51(xviii).
51
Pila, supra note 11 at 327.
52
Ibid.
53
Pila, ibid at 369.
54
Pila, ibid at footnote number 150. For example, the U.
K. Courts of Appeal applied narrow interpretation of
the EPC Art. 52(2) in Genentech, Inc. v. Wellcome
Found., 1989 R.P.C. 147 (Eng. C.A. 1988).
55‘Trilateral Co-operation of the US, European andJapanese Patent Offices’ (1988) 7 Biotechnology Law
Review 159, 163 cited in R Crespi, ‘Patenting andEthics: A Dubious Connection’ (2001/2002) 5
Bio-Science Law Review 71. See Australian Law
Reform Commission, Genes and Ingenuity: Genepatenting and human health (ALRC 99) (Government ofAustralia, June 2004) [Australian Law Reform
Commission],
online:http://www.austlii.edu.au/au/other/alrc/publications/repo
rts/99/ (visited on Feb. 6, 2014).
56
Pila, supra note 11 at 377.
57
Kwan Kiat Sim, Rethinking the mandatory/discretionary
legislation distinction in WTO jurisprudence, World
Trade Review (2003), Vol. 2, Issue 1, page 59. See
Article 26 of the Vienna Convention of the Law ofTreaties 1969.
58
OPPENHEIM’S INTERNATIONAL LAW (Robert
Jennings and Arthur Watts ed., 1992, Longman),
Section 21 at 83.
59
The Marrakesh Agreement Establishing the World
Trade Organization, Apr. 15, 1994, 33 I. L. M. 1144
(1994) at art. XVI, para 4 [hereinafter WTO
Agreement].
60
The Agreement on Trade-Related Aspects ofIntellectual Property Rights, Apr. 15, 1994, Annex 1C,
33 I. L. M. 1197 (1994) at art. 1(1) [hereinafter TRIPS
Agreement].
61
Brian Fitzgerald, INTELLECTUAL PROPERTYSYMPOSIUM: Theoretical Underpinning of Intellectual
Property: “I am a Pragmatist But Theory is my Rhetoric,”
16 Can. J.L. & Juris. 179, July 2003 at page 188.
62
Ibid.
63
Interview with Professor Yoshiyuki Tamura, Director,
Research Institute for Information Law & Policy, Schoolof Law, Hokkaido University, Japan on January 25, 2014.
49

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