HYGIA INSTITUTE OF PHARMACEUTICAL
EDUCATION AND RESEARCH
Faizullahganj, Prabandh Nagar, Ghaila Road, Lucknow
(226020)
LEGAL PROTECTION OF INNOVATIVE
USES OF COMPUTERS IN R&D
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CONTENTS
Intellectual Property Rights
Patents
Patents on Algorithms
Patents on Human Interfaces
Patents on Machine-Machine Interfaces
Patents on Data Structures
Copyright
Protection of Databases
Trade Secrets
Enforcement of Rights
References
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Intellectual Property Rights
The term “intellectual property rights” is used to describe
the legal instruments for protecting innovation. Although
there are often differences in the laws governing these rights
in different countries, almost all countries recognize the
basic types of intellectual property.
Every Member of states of the World Trade Organisation
have all committed to introducing these rights. Of these
rights, the most important in the application of computers to
pharmaceutical research and development are patents,
copyrights, and database rights (1).
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Type of IPR Protects Maximum Lifetime (generally—
may vary from country to country)
Patent Technical ideas 20 years from filing
Copyright Literary works including computer 70 years from death of author or
programs date of creation (in the case of joint
works)
Database Collection of data (only exists in the 70 years from the date of creation
rights European Union and some other
countries—the US is discussing the
proposal)
Trade Secret no disclosed Unlimited, as long as access is
secrets information limited to a select group
Design Aesthetic creation (generally not Varies from country to country; 25
relevant in the pharmaceutical field) years in the European
Union from application; 14 years in
the United States from grant
Trademarks Brand name or sign designating a Unlimited, as long as the trademark
product remains in use
Patents
Patents are the most important and strongest type of
intellectual property. Patents protect inventions or technical
innovations. Patents do not protect new designs (these are
protected by copyright or registered designs), nor do they
protect new brand names (trademark protection).
In the application of computers to pharmaceutical
applications, both hardware inventions and software
inventions can be protected by patents.
The hardware might consist of a microarray, a processor,
memory and a display device. The software would consist
of the set of instructions processed in the processor for
processing data obtained from the microarray and stored in
the memory (2).
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Cont…..
Hardware inventions are clearly patentable and despite
misgivings in some quarters, it is now generally recognized
that software can be protected by patents.
In the United States, the decision of the Court of Appeal in
the so called “State Street” case opened the way for much
more far-reaching patent protection for computer-
implemented inventions than had been previously granted.
In that decision the Court stated that the sole test for
determining whether an innovation is patentable is whether a
“useful, concrete, or tangible” result was obtained (2).
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Patents on Algorithms
Analysis of data in pharmaceutical research and
development was carried out essentially by manual
processes, the volume of data that is currently being
generated means that increasingly sophisticated algorithms
are being used to order, sort, and analyze the data.
The European Patent Convention clearly states that
scientific theories and mathematical methods are not to be
regarded as being inventions. if a new technical aspect is
involved then it grants Patent.
USPTO (Washington, DC) and the US courts are looking
for a concrete, useful, and tangible result to justify the grant
of a patent (2).
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Cont…..
Any algorithm used in the analysis of data, such as DNA
sequence or protein data, should be patentable as long as it
is not couched in purely mathematical terms but is applied
to achievement of a useful, concrete, and tangible result.
Example, an algorithm such as the Smith–Waterman
algorithm to identify homologies among proteins would
have been patentable because it offers a useful, concrete,
and tangible result.
Similarly, an algorithm to mine data for potentially useful
properties of a drug or for monitoring side effects of a drug
is also protectable.
Another example would be an algorithm that efficiently
searches annotations (comment added to text or diagram) in
databases for information about potential adverse side
effects (2).
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Patents on Human Interfaces
Given the amount of data that can be potentially provided
to the researcher, efficient means are needed to present the
data in a readily understood manner.
In Europe such methods of presenting information are
excluded from patent protection.
However, several decisions from the European Patent
Office indicate that patents might be granted if the
information presented is more than just “mere” data.
In the United States the Patent Office is likely to be less
restrictive in issuing patents because the methods of
presenting information are not excluded from patents (2).
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Patents on Machine-Machine Interfaces
Unlike patents on machine-human interfaces, patents are
regularly granted in both the United States and in Europe on
the interfaces to a computer program
Such patents can be extremely valuable as they can allow
the creator of the computer program to limit the access to the
computer program only to others to whom a license to use
the interface has been granted.
The use of patents on machine-machine interfaces can be
illustrated by considering the example of a microarray. The
data obtained by the microarray can be processed by any
computer system running a suitable program.
The data are transferred from the microarray to the
computer system through an interface, and use of a patented
interface can be restricted only to the patent holder and its
licensees (2).
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Patents on Data Structures
The application of computer programs to pharmaceutical
research and development was focused on the construction
of databases to record data generated by drug testing, high-
throughput screening, or gene sequencing experiments.
The experimental data in such early databases were often
stored in a simple flat file structure.
The structure of these databases can be protected by
patents.
In the United States computer memory with a novel
hierarchical and relational data structure ,The patent was
allowed (2).
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Copyright
Copyright is traditionally used to protect literary works.
In the United States, software is protected as a literary work and
registration of the copyright is carried out at the US Copyright
Office.
The situation in Europe was more complicated as protection was
granted under national laws rather than on an EU-wide basis.
In 2002 the World Intellectual Property Organisation (WIPO)
Copyright Treaty of 1996 entered into force for a number of
countries, including Japan and the United States. Signatories to this
treaty must ensure that computer programs are protected as literary
works.
Copyright only protects the innovation, that is the computer code,
and protection does not extend to the innovation itself.
In other words, the idea behind the program can be copied, as
long as the code itself is not copied or adapted (3).
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Protection of Databases
A database can be protected either by copyright protection or by so-
called database rights.
The European Union adopted the European Database Rights Directive
to harmonize protection of the information contained within databases.
The directive protects “a collection of independent works, data or
other materials arranged in a systematic or methodical way.
A developer of a database can prevent the extraction and/or reuse of
all or a substantial part of the contents of the database accessible by
electronic or other means.
For example, a database comprising genome sequence data or protein
structure data can stop others from using these data without permission.
Unfortunately, protection under the European Database Rights
Directive is limited only to persons or legal entities residing in the
European Economic Area (the European Union, Norway, Iceland, and
Liechtenstein) (3).
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Trade secrets
Trade secret protection is probably the weakest of all intellectual
property rights.
The US Uniform Trade Secret Act defines a trade secret as
information, including a formula, pattern, compilation, program
device, method, technique, or process.
Trade secret protection is available only for information that is
known to a smallish group of persons and that is considered by that
group to be confidential and economically valuable.
Once the information becomes more widely known, it no longer
qualifies for trade secret protection because its value has been lost.
As a result, once the information has become generally known, it
can be freely used by other companies for their own purposes.
Trade secrets (or “undisclosed information”) are also protected
under the TRIPS (Trade related aspects of Intellectual Property
Rights ) Agreement (4).
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Cont….
Trade secret protection can play a significant role in the
protection of computer software.
Data on the efficacy of new drugs, as long as their
origination requires considerable effort, are also protected
under the TRIPS Agreement .
The regulatory authorities are required to keep the
information supplied confidential (4).
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Enforcement Of Rights
Obtaining IP protection is only the first step. The intellectual property
rights obtained are only useful if they can be exploited and—ultimately
—unauthorized users of the rights can be stopped from exploiting them.
This presents a fairly unique problem in the computer science field. IP
rights are essentially national rights. They are only valid in the country
in which they are granted or registered. A valid US patent is only valid
in the United States, a Canadian copyright only valid in Canada.
Even a so-called European patent is, in effect, a bundle of national
patents valid in various European countries. This raises a problem in a
situation in which, for example, the user of a computer program is in
one country and the server is in another country.
Courts in both the United States and the United Kingdom have had to
deal with this issue in patent infringements unrelated to pharmaceutical
science (1).
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References
1. Toner B. Bioinformatics patents remain a rarity in IP-
heavy biopharmaceutical industry. Genome Web, 4 July
2001 ([Link]
2. Steinberg D. New PTO Unit examines Bioinformatics
Application. The Scientist 27 November 2000;200:14(23);8.
3. Adapted from Robert Harrison, Protecting innovation in
bioinformatics and in silico biology. Bio drugs
2003:17(4):227–31.
4. TRIPS Agreement (Agreement on Trade Related Aspects
of Intellectual Property). Available at URL
[Link]
01_e.htm.
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