See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/355910311

Intellectual Property Rights and Computer Applications for Pharmaceutical

Research and Development

Article · November 2021

DOI: 10.2174/2667337108666211103105845

CITATIONS READS
3 1,365

2 authors, including:

Dnyanesh Saindane
SVKM’s NMIMS School of Pharmacy and Management
8 PUBLICATIONS 97 CITATIONS

SEE PROFILE

All content following this page was uploaded by Sankha Amalkrishna Bhattacharya on 03 December 2021.

The user has requested enhancement of the downloaded file.

 Send Orders for Reprints to [email protected]
Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, 8, 1-0 1
REVIEW ARTICLE

Intellectual Property Rights and Computer Applications for Pharmaceuti-

cal Research and Development
Sankha Bhattacharya1,* and Dnyanesh Saindane1

1
Department of Pharmaceutics, Narsee Monjee Institute of Management Studies, School of Pharmacy & Technology
Management, SVKM'S NMIMS Deemed-to-be University, Shirpur, Maharashtra 425405, India

Abstract: Intellectual Property Rights (IPR) are intellectual privileges that allow authors and inven-
tors to defend their original inventions from misuse or theft. With the assistance of algorithms, clin-
ical science has taken on a different level in recent years. Various advanced tools can be used to in-
ARTICLE HISTORY
vestigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic
Received: April 20, 2021 effects, and so on. Computational scientists are making continuous efforts to figure out how to con-
Revised: June 30, 2021 nect business models in pharmacology. However, software theft and security rights remain major
Accepted: September 01, 2021
concerns for all. In order to avoid such violations, IPR compliance for R&D as well as promoting
DOI: machine applications is critical. This compilation will illustrate diverse software concepts, the lat-
10.2174/2667337108666211103105845 est patent data structures, copyright management laws for software, trade secrets, compliance
rights, software patenting and contracts, artificial technology priorities and problems, licenses, and
case studies relating to IPR violations in pharmaceutical and other fields.

Keywords: IPR, IP protection, copyrights, patent, software licensing, artificial intelligence.

1. INTRODUCTION bases is also important to avoid any misuse and also to pro-
tect its IPR from infringement [3]. Also, when these algo-
Software, commonly known as programming, is a chal-
rithms or human machine interfaces are integrated with the
lenging asset to maintain. A wide range of Intellectual Prop-
real-time equipment, we say it as a software-hardware inte-
erty Rights (IPR) may provide protection during the transitio-
gration, and to protect this is also important [4]. Soft-
nal stage between pure psyche-generated works and special-
ware-hardware integration can be achieved by a sensor and
ized innovations. Intellectual property (IP) is a critical tool
connector in which a sensor converts the analogue signal
for protecting programming or software innovation and inno-
from hardware to digital data for processing by a computer
vation in other fields [1]. A software invention patent may
and a connector, which usually helps in data transfer be-
be used to prohibit others from using a certain algorithm
tween a hardware and a computer [5]. In this chapter, differ-
without permission or from developing software pro-
ent software protection activities, software licensing, and
grammes that fulfil patent-protected activities. A trademark,
rules are discussed along with software-hardware integra-
on the other hand, may protect a software's name, brand, lo-
tion, protection of hardware i.e., innovative equipment’s re-
go, and catchphrases, as well as prohibit rivals from using
lated to computer and technology and regulations of soft-
similar names. The code that operates the programme is not
ware protection in R&D sector and different case studies re-
protected by trademarks. Copyright, on the other hand, may
lated to software related IPR and their significance to
be used to prohibit complete duplication of a software pro-
strengthen the social economy are also discussed [6]. The
gramme as well as duplicating any part of the software code
stages of software development are depicted in Fig. (1), as
under literal infringements of copyright act. In any case, the
well as areas where Intellectual Property Rights (IPR) such
way to make such esteem can change impressively, relying
as patents, copyrights, and trademarks may be important.
upon the misapplication plot picked and the related environ-
ment for which the utilization of programming improve- 2. INTELLECTUAL PROPERTY RIGHTS
ments is planned. Plans of action are then formalized in an
agreement, which for the most part appears as permit unders- New investors will not be able to enjoy the monopoly of
tandings, forcing explicit utilization administers on outsiders IPR rights unless and until they can demonstrate that one‘s
proposing to misuse the product [2]. Legal protection of al- invention is unique or has some additional inventive steps
gorithms, machine interface, data structures, and also data- than existing technology [7]. The most significant edge of
IPR law enforcement is working in two dimensions, i.e., in
first, IPR protects inventor or author rights for exploiting
* Address correspondence to this author at the Department of Pharmaceu- commercially for the limited period Viz patents 20 years and
tics, Narsee Monjee Institute of Management Studies, School of Pharmacy
& Technology Management, SVKM'S NMIMS Deemed-to-be University,
six years in the case of copyrights [8]. In second, if someone
Shirpur, Maharashtra 425405, India; Tel: +917878777207; violates IPR rights or infringes them for their own benefits
E-mail: [email protected] without

2667-338X/21 $65.00+.00 © 2021 Bentham Science Publishers

2 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

Fig. (1). Impact of Intellectual Property Rights (IPR) on Software Development. (A higher resolution / colour version of this figure is avail-
able in the electronic copy of the article).

prior consent from the inventor, then the IPR law allows en- venting the software in the mid-1800s [16, 17]. Intellectual
forcing stringent punishment and considerable penalties to property rights are considered as the basic and core of the
the patent violators [9]. It was observed that developed na- software industry. Innovation and research work in the field
tions had utilized IPR to uplift their economy, but the laxity of computer and software can be safeguarded by various in-
of proper enforcement of IPR law can lead to discrimination tellectual property rights like patents, trademarks, and copy-
and ambiguous outcomes [10]. Therefore, it was necessary rights. Trademarks cannot directly protect the software it-
to establish an international convention to control the piracy self. Instead, it protects the name and or symbols that are spe-
of IPR laws. On January 1, 1995, the General Agreement on cific to any product or company [18]. Whereas patents and
Tariffs and Trend (GATT) was incepted. Later, the GATT trademarks directly safeguard the software itself, thereby
name was changed to World Trade Organisation (WTO) avoiding infringement and misuse. In general, copyright pro-
[11]. To protect IPR law there are many international con- tection applies to the secure expression of some idea or con-
ventions on intellectual property applied, such as; Paris con- cept instead of protecting the concept or idea itself [19]. The
vention on IPR like patent and designs, the Berne conven- idea of copyright protection of software or software prod-
tions for the protection of literacy and artistic works, Rome ucts was governed globally by the World Trade Organiza-
convention for the protection of performances and producers tion’s (WTO) agreement on Trade-Related Aspects of Intel-
of phonograms and broadcasting organizations, Washington lectual Property Rights (TRIPs) [20]. In Table 1, various
conversion on integrated circuits and Geneva convention for IPR-influenced softwares have been thoroughly discussed.
the protection of new plant varieties [12, 13].
4. ENFORCEMENT OF IPRS AND LICENSING
3. HISTORY AND BEGINNING OF IPR IN THE
FIELD OF COMPUTER/SOFTWARE In Fig. (2), “None” or “Some” comes under free and
open-source license where inventor rights would be protect-
Computer was introduced back in 1880 in the U.S for a ed using patent, copyright. Free source of software is dist-
severe emergency related to numbers [14]. Due to the sud- inct by free software foundation. In the same way, open--
den rise in population in the United States, the tabulation of source software is different from open-source initiative.
census data and analysis of census results became a tedious Even though their objectives are the same, but the most signi-
task. To perform such a tedious task in a short period and at ficant difference is the free software foundation entertained
a faster rate, the government opted to choose punch- card- metaphysical properties of the software where else, open-
based computers. These computers were enormous and took source software seeks more commercial benefits. Surprising-
up almost a whole room [15]. Such huge size was consid- ly, many widely used licenses such as GNU General Public
ered one of the drawbacks of the computers and at that time Licence and European Public Licence were owned and
one would surely say that idea of computers and software amended by the free software foundation. Most of the soft-
would flop. But as time passed, the size of computers be- ware need to seek approval for their label from the open-
came normal and the use of computers in day-to-day life be- source initiative and free software foundation [21-23].
came normal. If we go through computer ventures' history, While preparing an open-source software license, four crite-
we can see that software was built long before the first elec- ria need to maintain viz., allow the license to run the pro-
tronic computers [16]. Charles Babbage is credited with in- gram, allow the license to study the modified program, redis-
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 3

tribution of unmodified copies, and allow the license to trans- ta was initially analyzed by manual process. In recent days
fer or distribute the modified version [24]. There is one spe- such huge data is now being handled by means of the algo-
cific category of license available, which is called an aca- rithm, but the algorithm as such is considered as an abstract
demic license. In this category, licenses are compiled with i.e., it is considered as a theoretical concept, and such things
all contracts which ignite license to run [25]. The academic are not considered as patentable [27, 28]. No patent office al-
licenses are usually extremely open, and the projects under- lows patenting any algorithm without its reference to any
going such licenses give proper recognition of authors [26]. sort of its practical application [29]. The European Patent
Convention clearly specifies that scientific ideas and mathe-
5. PATENTS INCEPTION IN THE ALGORITHM, MA- matical methods cannot be considered inventions. As dis-
CHINE INTERFACE, AND DATA INTEGRITY cussed above, to justify the issuance of a patent, the USPTO
(Washington, DC) and the US courts are searching for a con-
5.1. Patenting of the Algorithm crete, useful, and tangible outcome. Patent security will be
Algorithms are one of the basic and crucial entities of obtained when an implementation of the algorithm is in-
the software industry. In the pharmaceutical industry, the da- volved [30].

Table 1. Different IPRs influence during software design.

Type of IPR Mandatory Registration Different Components of Software’s

Copyright Using i-DEPORT service, the compulsory solution is The copyright law aims to protect the software licence as well as the necessary
available. In some countries, the requisition is also avail- code. It is also helping to protect graphical element such as icon
able
Patent Registration is mandatory for filing any sort of patent; Patent seeks to provide functional dimension and proprietorship of new ad inven-
without prior registration, no patent can be filed tive technique
Industrial design It is necessary to do registration, even though there are It seeks to provide protection to the graphical use of the software interface
certain provision where unregistered design can be pro-
tected
Trade marks It is highly advisable to seek registration In this provision, virtual logo and textual nature of the software can be protected
Database rights No need of any registration IPR in computer software data management is important because a data base can
be a very essential component of any software and it may be used by others with-
out permission
Trade secrets No need of any registration By applying contractual agreement, very genuine and specific information can be
arranged

Fig. (2). Several types of rights were reserved when intellectual property rights in software were created. (A higher resolution / colour ver-
sion of this figure is available in the electronic copy of the article).
4 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

5.2. Patenting Human-Machine and Machine-Machine 5.4. Data Integrity

Interface Data integrity is defined as the process in which all the
A human researcher must communicate with most com- informed raw data are presented systematically, accurately
puter programmes to be used in pharmaceutical research and throughout the data lifecycle. Data can be hybrid or pa-
development [31]. Effective means are required to present per-based. Data integrity provides a platform to retain,
the data in a readily understood way considering the amount archive, and retrieve the data [45]. Mostly, for the quality,
of data that can theoretically be presented to the researcher safety, and efficacy of the drug, improvising of the quality
and such a system is called a Machine-Human interface product profile data integrity is essential [46]. If anyone sub-
[32]. Similarly, when the communication is between the two mitted false data to USFDA, which is directly the mis-
machines, which may include industrial instrumentation, en- conduct of data integrity, then as per FD& C act, the com-
abling a sensor (like temperature, pressure), and many more, pany or the investor may receive a warning letter or in ex-
such systems are called Machine-Machine interface. Patent- treme condition, no further approval from USFDA. As per
ing Human-Machine interface type of data is not considered USFDA, there are many provisions for data integrity Viz.
patentable in Europe [33]. The Patent Office in the United Accurate transcription without source document, wiping e-
file after printing, data manipulation, withdrawing critical in-
States is likely to be less stringent in granting patents be-
formation with misrepresentation. As per 21CFR, Part 11 of
cause patents are not exempted per se from the methods of USFDA, data integrity is critical to regulatory compliance.
presenting such data related to the Human-Machine inter- ALCOA is a possible technique for data quality compo-
face [34]. It is indeed probable that for this reason, a patent nents, particularly when using data as evidence of com-
issued in the United States could be denied in Europe. Sever- pliance with regulatory standards. ALCOA stands for At-
al European Patent Office decisions suggest that patents tributable(A), Legible(L), Contextualized(C), Original(O),
may be awarded if the information submitted is more than and Accurate(A), and it is shortened as ALCOA. Stan W.
just “mere” data [35]. This is explained by taking the exam- Woollen, a former FDA Officer of Enforcement, coined this
ple; the European Patent Office has issued a patent on a acronym in the 1990s. The four additional qualities given by
method for showing one of a series of predetermined mes- the European Medicines Agency (EMA) to complete the
sages indicating a particular event that may occur on a word idea are comprehensive, consistent, long-lasting, and easily
processing system input/output unit [36]. The European available: This brings attention to data management require-
Board of Appeal has claimed that it is fundamentally a tech- ments that were only partly covered in the original five. In
nical issue to provide visual indications automatically of the the industry, this extended concept is known as ALCOA+.
conditions prevailing in an apparatus or system and is there-
The following Fig. (3) explains about data integrity prop-
fore not exempt from patentability [37].
erly of ALCOA elements.
5.3. Patents on Database and Data Structure 5.5. Is your Document ALCOA Compliant?
The database can be defined as data organized in a wel- Data integrity is an essential tool for IPR protection. It
l-structured manner that can be easily accessed, managed, can be explained by citing example; on June 29, 2006, one
and updated [38]. The creation of databases to record data US patent was published by Battat et al. (US 2006/0143239
produced by drug testing, high-throughput screening, or A1) entitled “Method and apparatus for maintaining data in-
gene sequencing experiments was the subject of much of the tegrity across the distributed computer system.” In this
early interest in applying computer programmes for pharma- patent, the inventors described an invention that can transmit
ceutical research and development [39]. The database in the an object from a server application to the client application.
pharmaceutical industry and drug development process is
vast, but such experimental data in early databases were 6. ARTIFICIAL INTELLIGENCE (AI)
used to be stored in a simple flat file structure [40]. Later, a
Artificial intelligence deals with the machine; it provides
relational database was made for a more effective and signifi-
skills and knowledge to the machinery and performs opera-
cant analysis of the data. These structured databases can be
tion and function faster and more accurately than human be-
protected by a patent but it is doubtful, though, that, without ings [47]. Artificial intelligence consists of conception of in-
any relation to its implementation, a claim to a database telligent machines that work with precision and respond like
structure per se will be seen to be patentable because the humans [48]. With the help of AI one can able to obtain opti-
structure itself does not yield a valuable, tangible, or con- mized “to perfect” pharmaceutical formulation and provide
crete product [41]. It will be more likely to approve a patent the desired product. John McCarthy is considered the father
application involving the application of the database struc- of Artificial intelligence (AI). In brief Artificial intelligence
ture to a specific pharmaceutical issue [42]. In one of the cas- simulates human intelligence with the help of machines, basi-
es involving the structure of data contained on or in a re- cally through computers. AI's most important component is
cord, the European Patent Office's Boards of Appeal have information engineering [49]. An artificial intelligence engi-
considered the question of patentability of the data structure neer is a person who works with conventional machine learn-
as a carrier used in an image retrieval system [43]. The pa- ing methods such as natural language processing and neural
tent application was originally dismissed on the basis that da- networks to develop models that are used to power artificial
ta submissions were exempt from patentability [44]. intelligence-based applications such as voice recognition.
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 5

6.1. Goal of AI tem that should be more capable of handling intricate

The major goal of Artificial Intelligence is to build the problems like human logic and reasoning [51]. Fig. (4) dis-
machine more intelligent and should able to handle the work cusses the application of Artificial Intelligence in the phar-
in the industries [50]. The other goal of AI is to build a sys- maceutical sector.

Fig. (3). ALCOA, which is defined as Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) by US Food and Drug Ad-
ministration standards, is data, whether it be paper or electronic. These simple principles should be included into data integrity profiling. (A
higher resolution / colour version of this figure is available in the electronic copy of the article).

Fig. (4). Aside from helping in the analysis of clinical trial data, another use of artificial intelligence in the pharmaceutical industry is the
identification of patients who may be interested in participating in the studies. In the pharmaceutical industry, employing artificial intelli-
gence-powered methods include using automated algorithms to perform time-consuming tasks that would otherwise be performed by hu-
mans. From the discovery of new and better medications to the prevention and treatment of quickly spreading diseases, artificial intelligence
has simplified and impacted the pharmaceutical industry in several ways. (A higher resolution / colour version of this figure is available in
the electronic copy of the article).
6 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

lenges, there are some limitations in the use of AI. In phar-

maceutical sciences, promising new medicines cannot be dis-
covered and optimised rapidly through AI.

7. ROLE OF ROBOTS USING AI IN THE PHARMA-

CEUTICAL FIELD

7.1. Robotic Pharmacist

In today’s world, in this hectic work pressure towards
the human beings, the man created a robot for the beneficial
and speedy work incorporating Artificial intelligence, so
that the robots can work same as humans [56]. Due to the
bulk volumes and hazardous conditions, some hospitals and
clinics exploit robotics to distribute medication to the patient
[57]. Although in the world, the utilisation of Artificial intel-
ligence and machine learning are increasing tremendously
and the usage of robots is expanding hastily in the hospitals,
clinics, and pharmaceutical companies [58]. The major ad-
vantage of robots is the reduction of errors and minimizing
the time period, which is considered one of the major advan-
tages. It may also have some drawbacks, but when used with
caution, it would be very helpful to mankind. The future of
AI in the pharmaceutical industry is discussed in Fig. (6).
Fig. (5). Multiple challenges of AI. (A higher resolution / colour
version of this figure is available in the electronic copy of the arti-
7.2. The Current Scenario in the Pharmaceutical Indus-
cle).
try

6.2. Challenges of AI Artificial Intelligence is tangled with computer systems

to perform tasks that need human intelligence [59]. It pro-
Artificial intelligence is surging as a growing field, but vides benefits in managing data and bestowing results that
all this comes with multiple challenges, and thus this chal- show betterment in decision making and aid in saving hu-
lenge can pose serious complications. Machine learning and man energy, cost, and time. Though traditional methods are
deep learning are considered as the requisite steps in AI used in many companies to run their healthcare business, to
[52]. They need the processing power of a supercomputer, implement this technology [60]. But some companies are
and, well, supercomputers are not inexpensive. While devel- not adopting this technology of Artificial intelligence; the
opers work more efficiently on AI systems because of the pharmaceutical industry can be affected in various ways
availability of Cloud Computing and parallel processing sys- such as Medical information, assortment and processing can
tems, they come at a price [53]. With an increase in the in- be reduced down. Inaccessibility of data and medical re-
flow of unprecedented quantities of data and a rapid increase cords, drug discovery and R&D process are costly and time-
in complex algorithms, not everybody can afford this [54]. consuming. Thus, while using the application of AI with ma-
This is one of AI's most significant obstacles, one that has chine learning is vastly necessary for making all the health-
kept researchers on the edge of corporate and start-up AI ser- care-related processes continuous, cost-effective, efficient
vices. These businesses can boast an accuracy of over 90%, and easy [61].
but in all these cases, people can do better. Let our model,
for example, predict whether the picture is of a dog or a cat. 7.3. Articulated Robots in Pharmaceutical R&D
Almost every time, humans can predict the correct perfor- Not only will the articulate robots have more joints than
mance, mopping up a remarkable accuracy of over 99%. SCARAs, but they would also have lateral and vertical
However, apart from this, there are several areas on the mar- joints, allowing them to move about with more flexibility.
ket where artificial intelligence can be seen as a better alter- Therefore, a Cartesian robot's work envelope is shaped like
native to conventional systems [55]. Awareness of Artificial a cub, a SCARA's work envelope is cylindrical, and an artic-
intelligence is the real question. There are only a small num- ulated robot's work envelope is shaped like a cub. Spherical
ber of individuals who are aware of AI's ability, apart from articulated robots, which have greater movement freedom,
technology enthusiasts, college students, and scholars, but can perform almost every function imaginable. The most
educating the general public and using it in day-to-day rou- used articulated robots have six limbs [62]. On the horizon-
tine will increase awareness among people. Different AI re- tal surface, the first reference rotates like a SCARA while
lated gadgets are now being used like smartwatches, smart the second two connections rotate in the vertical plane. Fur-
bands, and different applications in mobile phones. Other thermore, six-dimension articulated robots have a vertically
challenges can be seen in Fig. (5), and due to several chal- rotating “forearm” and vertically revolving “wrist” arm that
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 7

Fig. (6). Future of AI in pharma sector: By enhancing candidate screening procedures for clinical trials, AI will also influence the future of
medicines. AI can assist guarantee trial adoption by rapidly assessing patients and finding the best prospects for a particular trial. (A higher
resolution / colour version of this figure is available in the electronic copy of the article).

enables them to make several of the same motions as a hu- poems, motion graphics, compositions, short stories, build-
man hand and wrist. Six-dimension articulated robots' limb ing design of source, movies, etc. In addition, copyright pro-
and wrist joints allow them to pick up an element from the tects against the procreation of an original work. Copyright
horizontal axis no matter how cantered it is and position it at is the legal tool that confers the author an exclusive right to
any appropriate approach angle. They also will enable the publish and market this work in a literary, cultural, theatri-
robot to perform a lot of tasks that would otherwise require cal, or other creative practice. Copyright holders are entitled
the dexterity of a human operator [63]. The articulated robot to monitor the propagation of their work along with the right
market is expected to go up from USD 10.92 billion in 2018 to obtain payments for that procreation. Protection of soft-
to USD 23.51 billion by 2023, at a CAGR of 16.58 percent ware is also given under copyright laws [66]. Software is
over the coming quarters; the industry is expected to report a protected as a literary work in the United States and copy-
shipment of 245.012 units in 2018 and is expected to reach right registration takes place at the US Copyright Office
548.566 units by 2023, at a CAGR of 17.49 percent over the (www.copyright.gov) [67]. Until 1991, as protection was
forecast timespan [64]. Growing applications of automation provided under national laws rather than on an EU-wide ba-
and increasing demand in developing nations from small sis, the situation in Europe was more complicated. Council
and medium-sized enterprises (SMEs) are key drivers for Directive 91/250/EEC of May 14, 2001, on the legal securi-
the articulated machine sector. However, a few of the main ty of computer programs implemented, within the EU Mem-
factors that restrain the articulated robot market's growth are ber States, a common protection under which software
the relatively high setup cost for applications and low manu- should be protected as a literary work. Until security was
facturing technology. granted, no conditions other than original authorship of the
8. COPYRIGHTS software were necessary [68].
The term copyright is the fusion of the two words copy 9. TRADE SECRETS
with right. Copyright means 'right to copy’ to be more pre-
cise in situations in which only the author or his authorized A trade secret is an information such as a formula‚ pat-
person has the right to procreate a work. Copyright is, in tern‚ compilation‚ programme‚ device‚ method, technique‚
plain words, a legal right held by the owner of a property or process deriving from its secrecy a unique and significant
[65]. To better grasp the definition of copyright, attention value. In other words, a trade secret is worthwhile because it
must be given to the elaboration. Special discoveries include is kept confidential [69]. Although the information can be
websites, computational physics, music lyrics, art, literature, useful or helpful to others‚ keeping the information secret‚
8 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

trade secret holders can monopolize the information for their elements or data may be protected by copyright laws or may
profit. For more information, see our trade secret law and be used to boost facts or otherwise ideas (see Bit Law for
trade secret litigation pages. even more knowledge on undefended ideas) [72]. A
Examples of the trade secrets include: database of statistics is often known as a list, meaning that
the collection includes ample original speech to protect valid-
● KFC Secret Mixture of 11 herbs and spices. ity [73]. A protectable collection of facts will be a collection
● Coca-Cola’s Signature Drinks Recipe. of web places for specified legal posts. Each boundary is in-
tegral of mere facts, namely that on the web at a location of
● The Search Algorithm for Google. the URL an article can be found. Depending on the nation
● McDonald's “special sauce” for big Mac. concerned, the degree to which material in the database may
be covered by copyright varies widely [74]. Copyright secu-
● Lists of Secret Clients at any company.
rity is not available in many countries for the material found
The advantages of foreign trade have become the princi- in databases. Other countries, such as Australia, consider
pal drivers of development for the final quarter of the twenti- that the organization and compilation of information may be
eth century [70]. Nations with high global trade have pros- of such value that the database may be subject to copyright
pered and can control Global Economy. International trade [75]. Whereas, the US Supreme Court dismissed the so-
can be one of the main contributors to reduce poverty [71]. called “sweat of the brow” theory in 1991, which had previ-
In his concept of competitive advantage David Ricardo, a tra- ously given copyright rights to material compilations [76]. It
ditional economist, explained how market can profit all par- is essential to use IPR laws properly to prevent software’s
ties if products are imported at distinct relative costs, such as piracy. When IPR protection is decided to enforce, then li-
individuals, companies and governments involved in it. The censing strategies need to be considered. As far as the soft-
net profits from these actions are called gains from trade. ware development is concerned, specifically for R&D pur-
The trade secret is considered probably the weakest intellec- pose, it can act as a tool for revenue generation [77]. A full
tual property rights. flagged understanding of exploitation strategies needs to be
enforced to get the best out of it. Software can be developed
10. PROTECTION OF DATABASE by diverse methods. Fig. (7) shows the reuse of previously
According to that same Copyright Act, a collection is available third-party components. But in some times, compo-
defined as a “collection and assembly of pre-defined aspects nent-based development faces some legal obligations as
or individual places in such a way that maximum work in its third-party software’s are not compatible to each other. This
totality denotes a creative piece of writings.” pre-determined is otherwise called licensing interoperability management.

Fig. (7). Re-use of the third-party component in software development: system reuse refers to reusing whole systems that may include numer-
ous applications. Apps may be reused by integrating them into other applications or by establishing application families. Reuse of application
components, from subsystems to single objects. (A higher resolution / colour version of this figure is available in the electronic copy of the
article).
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 9

11. CASE STUDIES RELATED TO IPR INFRINGE- and hence the product was not created directly by the same
MENT IN PHARMACEUTICAL INDUSTRY procedure. As a result, the patent was not infringed upon.
The British company's sales were anticipated to be down
11.1. Case 1 - Generic Drug Manufacturer in Vietnam
by EUR 30,000. However, the legal fees amounted to EUR
vs. British Pharmaceutical Company
50,000.
11.1.1. Background
11.2. Case 2 - European Pharmaceutical company vs.
For the past 20 years, a British pharmaceutical company Vietnamese Pharmaceutical Company
has been the global leader in the creation of an anti-cancer
medicine, which it has been exported to every major indus- 11.2.1. Background
trialised country, as well as emerging ones, particularly in A European pharmaceutical manufacturing company
Southeast Asia. The drug's active ingredient was patented found two companies in Vietnam in 2015 peddling locally
(product patent), however, the patent had expired three years manufactured APIs containing the gamma-crystalline ver-
ago. Therefore, a better new procedure for manufacturing sion of an active component for which the European com-
the medicine was patented ten years ago (process patent), pany held a valid Vietnamese patent. This patent infringe-
and it is still active in several countries, including Singa- ment case was unique in that it was the first time a crystal-
pore, Malaysia, and Indonesia. The firm discovered that a line form of a copyrighted substance had been infringed up-
generic manufacturer headquartered in Vietnam was manu- on in Vietnam. The patented chemical had been the subject
facturing and exporting the anti-cancer treatment to of all previous pharmaceutical patent challenges.
Malaysia, where it was being marketed for half the price of
their own drug. This had a significant negative impact on 11.2.2. Action taken by Innovator
sales.
X-ray diffraction testing was used to determine patent in-
11.1.2. Action Taken by Innovator fringement. Because Vietnam is unable to conduct the test,
the testing was held in France. Based on the findings, the
Patents are international rights; thus, the British firm was Vietnam Intellectual Property Research Institute (VIPRI)
told that action could only be pursued in nations where a pa- and a French scholar were consulted about the probability of
tent existed. If a third party creates, imports, sells, proposes patent infringement. An X-ray diffraction test was used for
to sell, stores, or uses a product without the patent owner's the first time to prove a pharmaceutical patent violation. Be-
authorization, the patent is infringed. A process patent is vio- cause the test could not be performed in Vietnam, the court
lated if a third party uses the method without the patent own- had to rely on an expert opinion from another country to
er's permission, as well as if a third party manufactures, im- make their judgement. This was also unheard of. Following
ports, sells, offers to sell, stores, or uses the product generat- the experts' advice, the corporation decided to take adminis-
ed directly from the process. The British producer was urged trative action against the first infringer through the Ministry
to consult a local specialist to identify the generic manufac- of Science and Technology (MOST).The second infringer,
turer's particular production steps. on the other hand, was known for clogging up administra-
tive processes with pointless demands (for example, asking
11.1.3. Outcome of the Case Study for the cancellation or invalidation of the counterpart patents
or attempting to put pressure on the authorities). In this case,
Because the original product patent filed in various he decided to make a request with IP Vietnam for the cancel-
Southeast Asian nations had already expired three years pri- lation of the European company's patent, expecting that the
or, no action could be taken against the generic manufactur- judges would put the civil action on hold while the adminis-
er for infringement of the product patent (it is possible they trative response was received. Because administrative action
would have had a longer term than those in developed coun- against the infringement would have been fruitless, a civil
tries due to differences in national laws). Furthermore, be- complaint was filed against him on December 1, 2017, in
cause no patents had been filed in Vietnam, no direct action Binh Duong Province.
could be taken against the generic producer for violation of
the process patent. It was not possible to extend the protec- 11.2.3. Decision Held by Court
tion to Vietnam because the process patent was filed and The court decided to take the case to trial on October 6,
published many years ago. The generic producer, on the 2018, and issued a final judgement on July 17, 2019, finding
other hand, was bringing the medicine into Malaysia. All but that:
one of the manufacturing steps used by the generic producer
were identical to those outlined by the patent claims, accord- 1. The defendant clearly committed patent infringement
ing to the local expert. when producing and distributing the infringing products dur-
ing the patent's term of validity; the court decided to take the
The claim called for a ‘aliphatic alcohol containing 1-3 case to trial on October 6, 2018, and issued a final judge-
carbon atoms' to be used as a solvent in the single non-identi- ment on July 17, 2019, finding that: 1. the defendant clearly
cal step, but the generic manufacturer utilised acetonitrile to committed patent infringement when producing and dis-
get the same result. The Malaysian court determined that us- tributing the infringing products during the patent's term of
ing acetonitrile instead of alcohol did not violate the patent, validity.
10 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

2. The defendant must recall all infringing medicinal The court's ruling followed the unfavourable Federal Court
products from the market for destruction. judgement in the SKB Shutters Manufacturing case from
2014.
3. The defendant must withhold all infringing medicinal
products from the market for destruction. 12.1. Outcome
4. The defendant must pay the plaintiff I VND 500 mil- 1. To reduce the danger of invalidation, it's critical to
lion in damages and (ii) VND 300 million in legal fees, plus grasp the conditions for patentability and carefully design
interest if payment is not made on time. your claims.
5. The defendant must apologise to the plaintiff in three 2. Hire a lawyer with experience and expertise in your
consecutive issues of Pharmaceuticals & Cosmetics mag- area to help you with patent prosecution, contract prepara-
azine, Health & Life magazine, and the Thanh Nien newspa- tion, and legal issues. It's also critical to be aware of local
per. court decisions in advance, such as precedents and, when
possible, the court's orientation and posture.
11.2.4. Outcome
3. Don't forget to research your alternatives and gather in-
The court's decision marked a number of tantalising le-
formation on local practices well ahead of time so that they
gal firsts, addressing a number of difficulties relating to pro-
may be incorporated into your business plan and strategy.
visions found in legal instruments that had never been imple-
mented in practice before: 4. Maintain an edge over competitors in the same area
by conducting frequent IP due to diligence operations to
1. It was the first time a Vietnamese court consented to
analyse the strength of your patent portfolio.
accept an expert opinion from outside the country as evi-
dence in a case. CONCLUSION
2. The application of statutory compensation up to VND It is obvious that management of IP and IPR is a multidi-
500 million was approved by the court. In actuality, the mensional task and calls for many different actions and
chances of success when claiming damages are usually fair- strategies which need to be aligned with national laws and in-
ly low due to numerous barriers (such as a lack of account- ternational treaties and practices [78]. It is no longer driven
ing books or documentation of damages). purely by a national perspective. The market must have a sig-
3. While the administrative office's decision on the pa- nificant impact on IP and its associated rights, market re-
tent cancellation was awaited, the courts were not required sponse, cost involved in translating IP into commercial ven-
to postpone the civil procedure. ture and so on [78]. In other words, trade and commerce con-
siderations are important in the management of IPR. Individ-
11.3. Case Dtudy - 3 uals with a range of topic knowledge, including science, en-
gineering, medical, legal, finance, marketing, and eco-
11.3.1. Background nomics, must participate in various intellectual property
A Malaysian Patent was owned by a foreign pharmaceu- (IPR) issues, which need distinct treatment, handling, plann-
tical business (“Foreign Company”) for a pharmaceutical ing, and strategies. Each industry should have its own intel-
product containing alendronic acid or a pharmaceutically ac- lectual property laws, management methods, tactics, and so
ceptable salt (alendronate) to decrease bone resorption in hu- on, depending on its area of competence. Pharmaceutical in-
mans. The National Pharmaceutical Control Bureau has ap- dustry currently has an evolving IP strategy. Since there ex-
proved a Malaysian firm (“Malaysian company”) to market ists the increased possibility that some IPR are invalid, an-
“Alendronate” 70 mg tablets. titrust law, therefore, needs to step in to ensure that invalid
rights are not being unlawfully asserted to establish and
11.3.2. Action Taken by Innovator maintain illegitimate, albeit limited, monopolies within the
pharmaceutical industry. Still, many things remain to be re-
The Foreign Company claimed that the Malaysian com- solved in this context. Due to the recent utilization of soft-
pany infringed on its registered patent by importing, manu- ware’s and online platforms while submitting very essential
facturing, offering for sale, selling, and stocking for the pur- documents in USFDA or in patent offices, the chances of
pose of selling or offering for sale “Alendronate” 70 mg piracy or data stealing become a more common factor. This
tablets. The Malaysian company counterclaimed, requesting is not only destroying the federal structure of any pharmaceu-
a determination that the patent in question is invalid for vari- tical R&D but it would also dethrone scientist’s morality. It
ous reasons. is therefore very much essential to protect IPR rights for the
inventors or any pharmaceutical company. In recent years,
12. DECISION HELD BY COURT many software companies also come up with some brilliant
The case was taken to the High Court, where the patent ideas to tackle such piracy and infringement. But some-
was found to be invalid due to a lack of creative steps. It is times, the robbers left no stone untrue to captivate entire
worth noting that all of the patent's dependent claims were computer data. Therefore, there must be some tough and se-
immediately declared invalid as a result of the independent cure firewalls to protect our important data. It is also needful
claim's invalidation, and no amendments were permitted. to improvise our data integrity system because data manipu-
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 11

lation in R&D is becoming a common practice elsewhere. http://dx.doi.org/10.1016/j.techfore.2020.120511

We are optimistic to get a stronger and powerful software [5] Liu H, Meusel P, Hirzinger G, Jin M, Liu Y, Xie Z. The modular
multisensory DLR-HIT-Hand: Hardware and software architec-
based IPR management system very soon. Use of artificial ture. IEEE/ASME Trans Mechatron 2008; 13(4): 461-9.
intelligence in the upcoming future is also of utmost impor- http://dx.doi.org/10.1109/TMECH.2008.2000826
tance for the overall research and development as also it can [6] Maskus KE. Intellectual property rights and economic develop-
be used in various aspects of IPR, but the challenges posed ment. Case Western Res J Int Law 2000; 32: 471.
[7] Maskus KE. Intellectual property rights in the global economy.
by artificial intelligence should also be considered. Washington: Peterson Institute for International Economics 2000.
Available from: https://www.piie.com/bookstore/intellectual-prop-
LIST OF ABBREVIATIONS erty-rights-global-economy
[8] Pandey N, Dharni K. Intellectual property rights. PHI Learning
IPR = Intellectual Property Rights Pvt Ltd 2014; 2014: 2685653.
[9] Green SP. Plagiarism, norms, and the limits of theft law: Some ob-
R&D = Research and Development servations on the use of criminal sanctions in enforcing intellectu-
al property rights. Hastings Law J 2002; 54: 167.
GATT = General Agreement on Tariffs and Trend http://dx.doi.org/10.2139/ssrn.315562
[10] Mutizwa J. Leading for the future: How to lead strategy across
WTO = World Trade Organization three time horizons, design the corporate dash-board, shape con-
text and drive execution in a turbulent environment. Africa: Par-
TRIPs = Trade-Related Aspects of Intellectual Property tridge Africa, Author Solutions, Incorporated, 2017.
Rights [11] Chaudhry PE, Walsh MG. Intellectual property rights: Changing
levels of protection under GATT NAFTA and the EU. Columbia J
USPTO = United States Patent and Trademark Office World Bus 1995; 30(2): 80-92.
http://dx.doi.org/10.1016/0022-5428(95)90027-6
CFR = Code of Federal Regulations [12] Hicks LL, Holbein JR. Convergence of national intellectual prop-
erty norms in international trading agreements. Am UJ Int Law
CONSENT FOR PUBLICATION 1997; 12: 769.
[13] Hertz AZ. Shaping the trident: intellectual property under nafta, in-
Not applicable. vestment protection agreements and at the world trade organiza-
tion. 23 Can- US LJ 1997; 23: 261.
FUNDING [14] Stedman LC, Kaestle CF. Literacy and reading performance in the
United States, from 1880 to the present. Res Q 1987; 8-46.
None. http://dx.doi.org/10.2307/747719
[15] Flood J. The fires: How a computer formula, big ideas, and the
best of intentions burned down New York city-and determined the
CONFLICT OF INTEREST future of cities. Penguin 2010; 2010: 114751072.
The authors declare no conflict of interest, financial or [16] Ceruzzi PE, Paul E, Aspray W. A history of modern computing.
London: MIT press 2003.
otherwise. [17] Rosen SJACS. Electronic computers: A historical survey. 1969; 1:
7-36.
ACKNOWLEDGEMENTS http://dx.doi.org/10.1145/356540.356543
[18] Denicola RC. Trademarks as speech: Constitutional implications
The author would like to acknowledge the help and moti- of the emerging rationales for the protection of trade symbols. Wis
vation of Dr. R.S. Gaud, Director, SVKM's NMIMS. Rev 1982; 2: 158.
Deemed-to-be University, Shirpur Campus, for providing ex- [19] Chisum DS, Ochoa TT, Ghosh S, LaFrance M. Understanding in-
tellectual property law. (2nd ed.), New York: LexisNexis 2011.
cellent research facilities and profound inspiration while [20] Sell SK, Prakash A. Using ideas strategically: The contest be-
drafting this book chapter. The author would also like to ac- tween business and NGO networks in intellectual property rights.
knowledge his original research publication entitled “Fabri- Int Stud Q 2004; 48(1): 143-75.
cation and characterization of chitosan-based polymeric http://dx.doi.org/10.1111/j.0020-8833.2004.00295.x
[21] Lucchi N. Intellectual property rights in digital media: A compara-
nanoparticles of Imatinib for colorectal cancer targeting ap- tive analysis of legal protection, technological measures, and new
plication”; for taking inputs from that article while drafting business models under EU and US law. Buff L Rev 2005; 53:
this book chapter. 1111.
http://dx.doi.org/10.2139/ssrn.704101
REFERENCES [22] De Laat PB. Copyright or copyleft?: An analysis of property
regimes for software development. Res Policy 2005; 34(10):
[1] Kean T. Cryptographic rights management of FPGA intellectual 1511-32.
property cores. Proceedings of the 2002 ACM/SIGDA 10th interna- http://dx.doi.org/10.1016/j.respol.2005.07.003
tional symposium on Field-programmable gate arrays. 2002 Feb [23] Fogel K. Producing open source software: How to run a success-
24 – 26; California, USA; 113-8. ful free software project. California: O'Reilly Media, Inc 2005;
http://dx.doi.org/10.1145/503048.503065 2005: p. 28870222.
[2] Loshin D. Business intelligence: The savvy manager's guide. 2nd [24] Laurent AM. Understanding open source and free software licens-
ed. Morgan Kaufmann 2012; 1-400. ing: guide to navigating licensing issues in existing & new soft-
[3] Miller AR. Copyright protection for computer programs, databas- ware. California: O'Reilly Media, Inc. 2004.
es, and computer-generated works: Is anything new since CON- [25] De Werra J. Moving beyond the conflict between freedom of con-
TU. Harv Law Rev 1992; 106: 977. tract and copyright policies: In search of a new global policy for
http://dx.doi.org/10.2307/1341682 online information licensing transactions-a comparative analysis
[4] Trappey A, Trappey CV, Hsieh A. An intelligent patent recom- between US Law and European Law. Colum JL & Arts 2001; 25:
mender adopting machine learning approach for natural language 239.
processing: A case study for smart machinery technology mining. [26] Lerner J, Tirole J. The scope of open source licensing. J Law Econ
Technol Forecast Soc Change 2021; 164: 120511. Organ 2005; 21(1): 20-56.
12 Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 Bhattacharya and Saindane

http://dx.doi.org/10.1093/jleo/ewi002 [47] Shang Y, Nguyen H, Bui XN, Tran QH, Moayedi H. A novel arti-
[27] Battat R, Her M, Sundaresh C, Vinberg A, Wang S. Computer As- ficial intelligence approach to predict blast-induced ground vibra-
sociates Think Inc. Method and apparatus for maintaining data in- tion in open-pit mines based on the firefly algorithm and artificial
tegrity across distributed computer systems. United States patent neural network. Nat Resour Res 2020; 29(2): 723-37.
US 7,680,879, 2010. http://dx.doi.org/10.1007/s11053-019-09503-7
[28] Sander T, Freyss J, von Korff M, Rufener C. DataWarrior: An [48] McCorduck P, Cfe C. Machines who think: A personal inquiry in-
open-source program for chemistry aware data visualization and to the history and prospects of artificial intelligence. Floride: CRC
analysis. J Chem Inf Model 2015; 55(2): 460-73. Press 2004.
http://dx.doi.org/10.1021/ci500588j PMID: 25558886 [49] Kasabov NK. Foundations of neural networks, fuzzy systems, and
[29] Thomas T Jr. The patenting of the liberal professions. BcL REv knowledge engineering. Massachusetts: Marcel Alencar 1996.
1998; 40: 1139. [50] Ge Z, Song Z, Ding SX, Huang B. Data mining and analytics in
[30] Merges RP. As many as six impossible patent before breakfast: the process industry: The role of machine learning. IEEE Access
Property rights for business concepts and patent system reform. 2017; 5: 20590-616.
Berkeley Technol Law J 1999; 14: 577. http://dx.doi.org/10.1109/ACCESS.2017.2756872
[31] Tichy WF. Should computer scientists experiment more? Comput- [51] Sloman A. Interactions between philosophy and artificial intelli-
er 1998; 31(5): 32-40. gence: The role of intuition and non-logical reasoning in intelli-
http://dx.doi.org/10.1109/2.675631 gence. Artif Intell 1971; 2(3-4): 209-25.
[32] Ehsani F, Knodt E. Speech technology in computer-aided lan- http://dx.doi.org/10.1016/0004-3702(71)90011-7
guage learning: Strengths and limitations of a new CALL [52] Harrer S, Shah P, Antony B, Hu J. Artificial intelligence for clini-
paradigm. Lang Learn Technol 1998; 2(1): 54-73. cal trial design. Trends Pharmacol Sci 2019; 40(8): 577-91.
[33] Vickers NJ, Baker TC. Chemical communication in heliothine http://dx.doi.org/10.1016/j.tips.2019.05.005 PMID: 31326235
moths. VII. Correlation between diminished responses to point-- [53] Froberg S. Distributed and cloud computing from parallel process-
source plumes and single filaments similarly tainted with a be- ing to the internet of things by Kai Hwang, Geoffry C. Fox, and
havioral antagonist. J Comp Physiol A Neuroethol Sens Neural Be- Jack J. Dongarra. Softw Eng Notes 2013; 38(2): 34.
hav Physiol 1997; 180(5): 523-36. http://dx.doi.org/10.1145/2439976.2439991
http://dx.doi.org/10.1007/s003590050069 [54] Song H, Liu H. Predicting tourist demand using big data in Analyt-
[34] Hahn C, Cowhig J. System and method for linguist-based human/- ics in smart tourism design. (1st ed..). Switzerland: Springer 2017;
machine interface components. United States patent application pp. 13-29.
US 14/300,733, 2015. http://dx.doi.org/10.1007/978-3-319-44263-1_2
[35] Graham S, Hall BH, Harhoff D, Mowery DC. Post-issue patent [55] Barr DJ. Pragmatic expectations and linguistic evidence: Listeners
"quality control": A comparative study of US patent Re-examina- anticipate but do not integrate common ground. Cognition 2008;
tions and European patent oppositions. NBER 2002; 2002: 109(1): 18-40.
15494823. http://dx.doi.org/10.1016/j.cognition.2008.07.005 PMID:
[36] Prevost SA, Bickmore TW, Sullivan JW, Churchill E, Girgensohn 18760407
A. Method and apparatus for embodied conversational characters [56] Moravec HP. Robot: Mere machine to transcendent mind. USA:
with multimodal input/output in an interface device. United States Oxford University Press on Demand 2000.
patent US 6,570,555, 2003. [57] Rosen JM, Kun L, Mosher RE, et al. Cybercare 2.0: Meeting the
[37] Hart RJ. Patentability of software at the european patent office. Int challenge of the global burden of disease in 2030. 2016; 6: 35-51.
Intell Prop Pol 1998; 2: 1. [58] Velásquez JD, Ríos SA, Eds. Knowledge-Based and Intelligent In-
[38] Srdoc A, Sluga A, Bratko I. A quality management model based formation and Engineering Systems 13th International Confer-
on the “deep quality concept”. Int J Qual Reliab Manage 2005; ence, KES; September 28-30, 2009; Santiago, Chile. Heidelberg:
22(3): 278-302. Springer 2009.
http://dx.doi.org/10.1108/02656710510582499 [59] Fahlman SE, Hinton GE. Connectionist architectures for artificial
[39] Pereira DA, Williams JA. Origin and evolution of high throughput intelligence. Computer 1987; 20(01): 100-9.
screening. Br J Pharmacol 2007; 152(1): 53-61. http://dx.doi.org/10.1109/MC.1987.1663364
http://dx.doi.org/10.1038/sj.bjp.0707373 PMID: 17603542 [60] Staw BM, Epstein LD. What bandwagons bring: Effects of popu-
[40] Roider HG, Pavlova N, Kirov I, et al. Drug2Gene: An exhaustive lar management techniques on corporate performance, reputation,
resource to explore effectively the drug-target relation network. and CEO pay. Adm Sci Q 2000; 45(3): 523-56.
BMC Bioinformatics 2014; 15(1): 68. http://dx.doi.org/10.2307/2667108
http://dx.doi.org/10.1186/1471-2105-15-68 PMID: 24618344 [61] Curtin J, Kauffman RJ, Riggins FJ. Making the ‘MOST’out of
[41] Gallagher WT. Book Review of Patent Failure: How Judges, Bu- RFID technology: A research agenda for the study of the adop-
reaucrats, and Lawyers Put Innovators at Risk. Bureaucrats, and tion, usage and impact of RFID. Inf Technol Manag 8(2): 87-110.
Lawyers Put Innovators at Risk 2009; 2009(Sep): 3. [62] Matta V, Moberg C. The development of a research agenda for
http://dx.doi.org/10.2139/ssrn.1467964 RFID adoption and effectiveness in supply chains. Issues Inf Syst
[42] Trask AV. An overview of pharmaceutical cocrystals as intellectu- 2006; 7(2): 246-51.
al property. Mol Pharm 2007; 4(3): 301-9. [63] Park YL, Chau K, Black RJ, Cutkosky MR. Force sensing robot
http://dx.doi.org/10.1021/mp070001z PMID: 17477544 fingers using embedded fiber Bragg grating sensors and shape de-
[43] Park J. Has patentable subject matter been expanded? -a compara- position manufacturing. Proceedings 2007 IEEE International Con-
tive study on software patent practices in the european patent of- ference on Robotics and Automation. 10-14 April 2007; Roma, Ita-
fice, the united states patent and trademark office and the japanese ly; pp. 1510-6.
patent office. Int J Law Inf Technol 2005; 13(3): 336-77. http://dx.doi.org/10.1109/ROBOT.2007.363538
[44] Ali-Yrkkö J, Hyytinen A, Pajarinen M. Does patenting increase [64] Joseph KJ. Growth of ICT and ICT for development: realities of
the probability of being acquired? Evidence from cross-border and the myths of the Indian experience. WIDER Discussion Paper
domestic acquisitions. Appl Financ Econ 2005; 15(14): 1007-17. 2002; 2002: 16780205.
http://dx.doi.org/10.1080/09603100500186978 [65] Liu JP. Owning digital copies: Copyright law and the incidents of
[45] McDowall RD. Data Integrity and Data Governance: Practical Im- copy ownership. Wm & Mary L Rev 2000; 42: 1245.
plementation in Regulated Laboratories. 2018. Available from: [66] Dam KW. Some economic considerations in the intellectual prop-
https://pubs.rsc.org/en/content/ebook/978-1-78801-281-2 erty protection of software. J Legal Stud 1995; 24(2): 321-77.
[46] Duan F, Wang EQ, Lam MG, et al. Superselective chemoembol- http://dx.doi.org/10.1086/467962
ization of HCC: Comparison of short-term safety and efficacy be- [67] Huang O. US copyright office orphan works inquiry: Finding
tween drug-eluting LC beads, quadraspheres, and conventional homes for the orphans. Berkeley Technol Law J 2006; 21: 265.
ethiodized oil emulsion. Radiology 2016; 278(2): 612-21. [68] Franke N, Von Hippel E. Satisfying heterogeneous user needs via
http://dx.doi.org/10.1148/radiol.2015141417 PMID: 26334787 innovation toolkits: the case of Apache security software. Res Poli-
Intellectual Property Rights and Computer Applications Applied Drug Research, Clinical Trials and Regulatory Affairs, 2021, Vol. 8, No. 2 13

cy 2003; 32(7): 1199-215. http://dx.doi.org/10.1016/j.patcog.2010.09.020

http://dx.doi.org/10.1016/S0048-7333(03)00049-0 [74] Eigenbrod F, Armsworth PR, Anderson BJ, et al. The impact of
[69] Chiappetta V. Myth, chameleon or intellectual property olympian- proxy‐based methods on mapping the distribution of ecosystem
a normative framework supporting trade secret law. Geo Mason L services. J Appl Ecol 2010; 47(2): 377-85.
Rev 1999; 8: 69. http://dx.doi.org/10.1111/j.1365-2664.2010.01777.x
[70] Rajan RG, Zingales L. The great reversals: The politics of finan- [75] Amano T, Sutherland WJ. Four barriers to the global understand-
cial development in the twentieth century. J Financ Econ 2003; ing of biodiversity conservation: wealth, language, geographical
69(1): 5-0. location and security. Proceedings of the Royal Society B: Biologi-
http://dx.doi.org/10.1016/S0304-405X(03)00125-9 cal Sciences 2013; 280(1756): 20122649.
[71] Brakman S, Garretsen H, Van Marrewijk C, Van Witteloostuijn [76] Drassinower A. Sweat of the brow, creativity, and authorship: On
A. Nations and firms in the global economy: An introduction to in- originality in Canadian copyright law. U Ottawa L & Tech J 2003;
ternational economics and business. Cambridge university press 1: 105.
2006. [77] Al-Aali AY, Teece DJ. Towards the (strategic) management of in-
http://dx.doi.org/10.1017/CBO9780511811791 tellectual property: Retrospective and prospective. Calif Manage
[72] Langvardt AW, Langvardt KT. Unqise or unconstitutional: The Rev 2013; 55(4): 15-30.
copyright term extension act, the eldred decision, and the freezing http://dx.doi.org/10.1525/cmr.2013.55.4.15
of the public domain for private benefit. Minn Intell Prop Rev [78] Saha CN, Bhattacharya S. Intellectual property rights: An
2003; 5: i. overview and implications in pharmaceutical industry. J Adv
[73] El Ayadi M, Kamel MS, Karray F. Survey on speech emotion Pharm Technol Res 2011; 2(2): 88-93.
recognition: Features, classification schemes, and databases. Pat- http://dx.doi.org/10.4103/2231-4040.82952 PMID: 22171299
tern Recognit 2011; 44(3): 572-87.

DISCLAIMER: The above article has been published, as is, ahead-of-print, to provide early visibility but is not the
final version. Major publication processes like copyediting, proofing, typesetting and further review are still to be
done and may lead to changes in the final published version, if it is eventually published. All legal disclaimers that
apply to the final published article also apply to this ahead-of-print version.

View publication stats