The document discusses the legal protection of innovative computer uses in pharmaceutical research and development, emphasizing the need for combined intellectual property (IP) strategies from pharmacology and computer science. It covers various types of IP rights, including patents, copyrights, and trade secrets, and highlights the challenges in patenting algorithms and bioinformatics. The conclusion notes the prevalence of computers in drug development and the importance of enforcing IP rights in this field.

1. LEGAL PROTECTION OF INNOVATIVE USES OF
COMPUTERS IN R & D
Dadasaheb Balpande College Of Pharmacy
Besa , Nagpur – 440037
2022-2023
Presented By : Guided By :
Tanvi D. Mhashakhetri Dr. Amol Warokar
M.Pharm Pharmaceutics Associate Professor
II Semester
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2. CONTENTS :
• Introduction
• 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
• Conclusion
• References
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3. INTRODUCTION :
• The days in which IP (intellectual property) strategists were separated into groups of
pharmacologists (chemists or biologists) and other groups of computer scientists are slowly
passing—in the same manner in which the technologies are increasingly overlapping in the
scientific world.
• Pharmacology patent lawyers had typically spent their training in the laboratory working with
chemicals or using polymerase chain reaction (PCR) techniques; they understood how small
molecular entities functioned and characterized sequences of RNA, DNA, and proteins.
• Computer scientists, on the other hand, spent hours programming computers and later writing
software and business method patents.
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4. • Just as understanding the application of computers in pharmacology presents a challenge for
researchers in both fields, it also means that the IP specialists also need to combine strategies from
both fields to obtain the best possible legal protection for innovation.
• A few years ago a study carried out by the London-based consulting firm Silico Research
reported that very few patent applications had been filed in bioinformatics.
• The reasons cited in the study for the scarcity of patents included the fact that many current
bioinformatics products merely combined existing data sources into a single product and the
difficulty of proving infringement of software patents.
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5. • The United States Patent and Trademark Office (USPTO) recognized in 1999 that
bioinformatics represented a special challenge and that same year created a special
examination group—Art Unit 1631—to examine the increasing number of applications .
• Since these studies were published, however, the growth in the number of bioinformatics
patents seems to have stalled.
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6. INTELLECTUAL PROPERTY RIGHTS
The term “ Intellectual property Rights” is used to describe the legal instrument for protecting
innovation .
There are intellectual property issues associated with four elements of a software program:
 Program function - whether the algorithm is performed by the hardware or the software,
 External design - the conventions for communication between the program and the user or other
programs,
 User interfaces - the interactions between the program and the user,
 Program code - the implementation of the function and external design of the program.
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7. The application of computers to pharmaceutical research and development are patents, copyrights,
and database rights.
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9. 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).
• 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.
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Memory
Display Devices

12. • 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.
• Hardware inventions are clearly patentable, and, despite misgivings in some quarters it is now
generally recognized that software can be protected by patents.
• The German Supreme Court, for example, has explicitly stated that the application of computers
in chemistry or biology is acceptable patentable subject matter .
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13. PATENTS ON ALGORITHMS
• Whereas until recently much of the 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.
• No patent office will allow the patenting of an without reference to its practical application.
• This certainly suggests that 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 result.
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14. • Thus, for example, an algorithm such as the Smith–Waterman algorithm to identify
homologies among proteins would have been patentable because it offers a useful , concrete
result.
• An example would be an algorithm that efficiently searches annotations in databases for
information about potential adverse side effects.
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15. PATENTS ON HUMAN INTERFACES
• Most computer programs for use in pharmaceutical research and development must interact
with a human researcher.
• 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.
• European patent officer indicated that patent might be granted if the information presented is
more than just “mere” data.
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16. 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.
• 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.
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17. PATENTS ON DATA STRUCTURES
• Much of the early interest in the application of computer programs to pharmaceutical research
and development was focused on the construction of databases to record data generated by
drug testing.
• The experimental data in such early databases were often stored in a simple flat file
structure.
• Subsequently, relational database structures were developed to allow the more efficient and
significant analysis of the data stored therein.
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18. • The structure of these databases can be protected by patents.
• Instead the detection is carried out automatically, and the results are fed into a computer.
• The computer program processes the data and produce them in a form that can be understood
and interpreted by a human.
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19. COPYRIGHT
• Copyright is traditionally used to protect literary works or works of art from copying or from
the making of so-called derivative works, that is, new works based on a protected work.
• More recently, protection under the copyright laws has been extended to software. In the
United States, software is protected as a literary work and registration of the copyright is
carried out at the US Copyright Office (www.copyright.gov).
• Council Directive 91/250/EEC on the Legal Protection of Computer Programs of 14 May 2001
introduced a common protection within the member states of the EU under which software was
to be protected as a literary work.
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20. • Copyright only protects the so-called “expression” of the innovation, that is, the computer code,
and protection does not extend to the innovation itself.
• Copyright protection can extend also to flow diagrams or pseudo code, and so these cannot be
used to create a new (derived) program.
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21. PROTECTION OF DATABASES
• In addition to the patenting of database structures, a database can be protected either by
copyright protection or by so-called database rights.
• The extent to which information in the database can be protected by copyright varies widely
depending on the country involved.
• A developer of a database can prevent the extraction and/or reuse of all or a substantial part of
the contents of the database .
• This means that a party that creates, for example, a database comprising genome sequence data
or protein structure data can stop others from using these data without permission.
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22. 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, that
1) derives independent economic value, actual or potential, from not being generally known to,
and not being readily ascertainable by proper means by, other persons who can obtain
economic value from its disclosure or use and
2) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy .
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23. • Trade secret protection can play a significant role in the protection of computer software.
• If the code is only released in object form and the source code is not readily available, then the
source code—so long as it is only known to a limited group of programmers—remains covered
by trade secret protection.
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24. 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.
• United States and the United Kingdom have had to deal with this issue in patent infringements
unrelated to pharmaceutical science.
• In the United States, the dispute centered around the popular Blackberry e-mail devices .
• A US company, NTP Inc., sued the makers of the Blackberry device, the Canadian company
Research in Motion, for patent infringement.
• Software or the results of the program being displayed on the user’s machine, it is probable
that a court would consider that to be sufficient to be a copyright infringement.
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25. CONCLUSION
The use of computers in developing new pharmaceutical products is nowadays common place, and
a number of tools and databases have been developed to improve their use. Although intellectual
property rights have to date rarely been the subject of court cases, protection is available and the
courts are prepared to enforce these rights, even in an international context.
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26. REFERENCES
1. Sean Ekins, A John Wiley & Sons, Computer Applications In Pharmaceutical Research And
Development , Inc., Publication Page no. 703-714.
2. Intellectual property rights and computer software by Dawn E. Bowman.
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